library(dplyr)Warning: package 'dplyr' was built under R version 4.3.3
Attaching package: 'dplyr'The following objects are masked from 'package:stats':
filter, lagThe following objects are masked from 'package:base':
intersect, setdiff, setequal, union#read csv
#df <- read.csv("CMS Rules.csv", stringsAsFactors = FALSE)
df <- read.csv("FDA Rules.csv", stringsAsFactors = FALSE)
# 2. Convert 'publication_date' to Date format
df <- df |>
mutate(publication_date = as.Date(publication_date, format = "%m/%d/%Y"),
year = format(publication_date, "%Y"),
month = format(publication_date, "%B")
)
# View the first few rows to verify
df title
1 Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers
2 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
3 Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program; Correcting Amendment
4 Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally- Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program; Correcting Amendment
5 Food and Drug Administration Enforcement Policy for Association of American Feed Control Officials-Defined Animal Feed Ingredients; Guidance for Industry; Availability
6 Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments; Correction
7 Medicare Program: Appeal Rights for Certain Changes in Patient Status
8 Medical Devices; Quality System Regulation Amendments; Correction
9 Medicare Program; Changes to the Fiscal Year 2025 Hospital Inpatient Prospective Payment System (IPPS) Rates Due to Court Decision
10 Medicare Program; FY 2025 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update; Correction
11 Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes; Correction
12 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2025 and Updates to the IRF Quality Reporting Program; Correction
13 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2025; Correction
14 Medicare Program; FY 2025 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, and Hospice Quality Reporting Program Requirements; Correction
15 Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE); Correcting Amendment
16 Medicare Program: Mitigating the Impact of Significant, Anomalous, and Highly Suspect Billing Activity on Medicare Shared Savings Program Financial Calculations in Calendar Year 2023
17 Medicaid Program; Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug Rebate Program
18 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
19 Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management
20 Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
21 Medical Devices; Immunology and Microbiology Devices; Classification of the Quantitative Viral Nucleic Acid Test for Transplant Patient Management
22 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System
23 Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers
24 Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System
25 Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements; Guidance for Industry; Availability
26 Medical Devices; Immunology and Microbiology Devices; Classification of the Whole Exome Sequencing Constituent Device
27 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Blood Collection Device for Cell-Free Nucleic Acids
28 Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Pancreatic Debridement Device
29 Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications; Correction
30 Medical Devices; Gastroenterology-Urology Devices; Classification of the Hemodialyzer With Expanded Solute Removal Profile
31 Food Additives Permitted in Feed and Drinking Water of Animals; Pichia Pastoris Dried Yeast
32 Medical Devices; Hematology and Pathology Devices; Classification of the Heparin and Direct Oral Factor Xa Inhibitor Drug Test System
33 Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Open Loop Fluid Therapy Recommender
34 Medical Devices; Dental Devices; Classification of the Radiofrequency Toothbrush
35 Medical Devices; Ophthalmic Devices; Classification of the Hydrophilic Re-Coating Solution
36 Medical Devices; Dental Devices; Classification of the Neuromuscular Tongue Muscle Stimulator for the Reduction of Snoring and Obstructive Sleep Apnea
37 Medical Devices; Neurological Devices; Classification of the Digital Therapy Device for Attention Deficit Hyperactivity Disorder
38 Medical Devices; Orthopedic Devices; Classification of the Intervertebral Body Graft Containment Device
39 Medical Devices; Physical Medicine Devices; Classification of the External Compression Device for Internal Jugular Vein Compression
40 Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age
41 Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting for Manufacturers
42 Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes
43 Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide; Guidance for Industry and Food and Drug Administration Staff; Availability
44 Food Additives Permitted in Feed and Drinking Water of Animals; Fermented Ammoniated Condensed Whey
45 Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Nucleic Acid Targets Including SARS-CoV-2 in Respiratory Specimens
46 Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Selected Microbial Agents That Cause Acute Febrile Illness
47 Medical Devices; General Hospital and Personal Use Devices; Classification of the Intravenous Catheter Force-Activated Separation Device
48 Medicare Program; FY 2025 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
49 Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE); Correcting Amendment
50 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2025
51 Medicare Program; FY 2025 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, and Hospice Quality Reporting Program Requirements
52 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2025 and Updates to the IRF Quality Reporting Program
53 Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry; Availability
54 Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants
55 Advisory Committee; Allergenic Products Advisory Committee; Termination; Removal From List of Standing Committees
56 Revocation of Authorization for Use of Brominated Vegetable Oil in Food
57 21st Century Cures Act: Establishment of Disincentives for Health Care Providers That Have Committed Information Blocking
58 Medicaid Program; Ensuring Access to Medicaid Services; Correction
59 Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality; Correction
60 Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting; Correction
61 Medicated Feed Mill License; Veterinary Feed Directive Drugs; Change of Address
62 Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
63 Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications
64 Food Additives Permitted in Feed and Drinking Water of Animals; Ethyl Cellulose
65 Laboratory Accreditation for Analyses of Foods; Program Implementation; Determination of Sufficient Laboratory Capacity for Import-Related Food Testing Covered by the Regulation
66 Administrative Destruction
67 Advisory Committee; Science Advisory Board to the National Center for Toxicological Research; Termination; Removal From List of Standing Committees
68 Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device
69 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species
70 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
71 Medicare Program; Updates to the Master List of Items Potentially Subject to Face-to-Face Encounter and Written Order Prior To Delivery and/or Prior Authorization Requirements; Updates to the Required Face-to-Face and Written Order Prior To Delivery List; and Updates to the Required Prior Authorization List
72 Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting
73 Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality
74 Medicaid Program; Ensuring Access to Medicaid Services
75 Clarifying the Eligibility of Deferred Action for Childhood Arrivals (DACA) Recipients and Certain Other Noncitizens for a Qualified Health Plan through an Exchange, Advance Payments of the Premium Tax Credit, Cost-Sharing Reductions, and a Basic Health Program
76 Medical Devices; Laboratory Developed Tests
77 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption Relating to Agricultural Water
78 Nondiscrimination in Health Programs and Activities
79 Food Additives Permitted in Feed and Drinking Water of Animals; Condensed, Extracted Glutamic Acid Fermentation Product
80 Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide; Availability
81 Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly (PACE)
82 Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program
83 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2024; Corrections
84 Medicaid Program; Streamlining the Medicaid, Children's Health Insurance Program, and Basic Health Program Application, Eligibility Determination, Enrollment, and Renewal Processes
85 Food Additives: Food Contact Substance Notification That Is No Longer Effective
86 Medical Devices; Technical Amendments
87 Frozen Cherry Pie; Revocation of a Standard of Identity and a Standard of Quality
88 Principles of Reasonable Cost Reimbursement; Payment for End-Stage Renal Disease Services; Prospectively Determined Payment Rates for Skilled Nursing Facilities; Payment for Acute Kidney Injury Dialysis
89 Advisory Committee; Genetic Metabolic Diseases Advisory Committee; Addition to List of Standing Committees
90 Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction
91 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
92 User Fees; Technical Amendment
93 Medicaid Program; Disproportionate Share Hospital Third-Party Payer Rule
94 Advisory Committee; Digital Health Advisory Committee; Addition to List of Standing Committees
95 Biologics License Applications and Master Files
96 Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program; Corrections
97 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction; Correction
98 Sensient Colors, LLC.; Filing of Color Additive Petition
99 Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program
100 Medical Devices; Quality System Regulation Amendments
101 Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories; Correction
102 Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements; Correction
103 Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
104 Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue; Confirmation of Effective Date
105 Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories
106 Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
107 Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations
108 Food Additives Permitted in Feed and Drinking Water of Animals; Calcium Formate
109 Revocation of Uses of Partially Hydrogenated Oils in Foods; Confirmation of Effective Date
110 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
111 Medicaid; CMS Enforcement of State Compliance With Reporting and Federal Medicaid Renewal Requirements Under Section 1902(tt) of the Social Security Act
112 Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt; Small Entity Compliance Guide; Availability
113 Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties; Correction
114 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction
115 Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format
116 Medicare and Medicaid Programs; Disclosures of Ownership and Additional Disclosable Parties Information for Skilled Nursing Facilities and Nursing Facilities; Medicare Providers' and Suppliers' Disclosure of Private Equity Companies and Real Estate Investment Trusts
117 Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program
118 Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements
119 Medical Devices; Hematology and Pathology Devices; Classification of the Container System for the Processing and Storage of Red Blood Cell Components Under Reduced Oxygen Conditions
120 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated With Section 1115 Demonstrations in the Medicaid Fraction; Correction
121 Medicare Program; Hospital Outpatient Prospective Payment System: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022
122 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
123 Listing of Color Additives Exempt From Certification; Jagua (Genipin-Glycine) Blue
124 Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements; Guidance for Industry; Availability
125 Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry; Availability
126 Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties
127 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated With Section 1115 Demonstrations in the Medicaid Fraction; Correction
128 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2024; Correction
129 Medicare Program; FY 2024 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update; Correction
130 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2024 and Updates to the IRF Quality Reporting Program; Correction
131 Requirements for Additional Traceability Records for Certain Foods; Technical Amendment
132 Streamlining Medicaid; Medicare Savings Program Eligibility Determination and Enrollment
133 Advisory Committee; Board of Tea Experts; Termination and Technical Amendment to the Citation for the Federal Advisory Committee Act
134 Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product-Compliance Policies, Revision 1; Guidance for Industry; Availability
135 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID-19
136 Medicaid Program and CHIP; Mandatory Medicaid and Children's Health Insurance Program (CHIP) Core Set Reporting
137 Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act-Compliance Policies; Guidance for Industry; Availability
138 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated With Section 1115 Demonstrations in the Medicaid Fraction
139 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID-19
140 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications, Change of Sponsor, Change of Sponsor Address
141 Revocation of Uses of Partially Hydrogenated Oils in Foods
142 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2024
143 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2024 and Updates to the IRF Quality Reporting Program
144 Medicare Program; FY 2024 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update
145 Medicare Program; FY 2024 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice Quality Reporting Program Requirements, and Hospice Certifying Physician Provider Enrollment Requirements
146 Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Correcting Amendment
147 Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants
148 Nomenclature Change for Dockets Management; Technical Amendment
149 Medicare Program; Treatment of Medicare Part C Days in the Calculation of a Hospital's Medicare Disproportionate Patient Percentage
150 Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Correction
151 Medicare and Medicaid Programs; Policy and Regulatory Changes to the Omnibus COVID-19 Health Care Staff Vaccination Requirements; Additional Policy and Regulatory Changes to the Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) To Provide COVID-19 Vaccine Education and Offer Vaccinations to Residents, Clients, and Staff; Policy and Regulatory Changes to the Long Term Care Facility COVID-19 Testing Requirements
152 Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly; Correction
153 Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments; Correction
154 Requirements for Additional Traceability Records for Certain Foods: What You Need To Know About the Food and Drug Administration Regulation: Guidance for Industry; Small Entity Compliance Guide; Availability
155 International Dairy Foods Association: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt; Correction
156 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
157 Medicare Program; Extending the Medicare Diabetes Prevention Program's (MDPP) Expanded Model Emergency Policy Through CY 2023
158 International Dairy Foods Association: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt
159 Medicare Program; Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly
160 Effective Date of Requirement for Premarket Approval Applications for Spinal Spheres for Use in Intervertebral Fusion Procedures
161 Medical Devices; Orthopedic Devices; Classification of Spinal Spheres for Use in Intervertebral Fusion Procedures
162 Change of Address; Technical Amendment
163 Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments
164 Medical Devices; Technical Amendments
165 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
166 Definition of the Term “Tobacco Product” in Regulations Issued Under the Federal Food, Drug, and Cosmetic Act
167 Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
168 Medicare and Medicaid Programs, CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Implementing Requirements for Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs To Provide Refunds With Respect to Discarded Amounts; and COVID-19 Interim Final Rules; Corrections
169 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address
170 Mammography Quality Standards Act
171 Change of Address; Technical Amendment
172 Medical Devices; Hematology and Pathology Devices; Classification of the Software Algorithm Device To Assist Users in Digital Pathology
173 Requirements for Additional Traceability Records for Certain Foods
174 Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021
175 Medical Devices; Cardiovascular Devices; Classification of the Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate
176 Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date
177 Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra; Notification
178 Medical Devices; Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions
179 Medical Devices; Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye
180 Radiological Health Regulations; Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products
181 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Prognostic Test for Assessment of Liver Related Disease Progression
182 Medicare Program; Updates to Face-to-Face Encounter and Written Order Prior to Delivery List
183 Medical Devices; Neurological Devices; Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions
184 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry; Availability
185 Medical Devices; Cardiovascular Devices; Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate
186 Medical Devices; Ear, Nose, and Throat Devices; Classification of the Powered Insertion System for a Cochlear Implant Electrode Array
187 Medical Devices; Orthopedic Devices; Classification of the Resorbable Shoulder Spacer
188 Medical Devices; Physical Medicine Devices; Classification of the Electroencephalography-Driven Upper Extremity Powered Exerciser
189 Medical Devices; Physical Medicine Devices; Classification of the Virtual Reality Behavioral Therapy Device for Pain Relief
190 Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
191 Medical Devices; Neurological Devices; Classification of the Brain Stimulation Programming Planning Software
192 Medical Devices; Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device
193 Medical Devices; Orthopedic Devices; Classification of the Bone Indentation Device
194 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID-19; Correction
195 Uniform Compliance Date for Food Labeling Regulations
196 Medical Devices; Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System
197 Medical Devices; Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid
198 Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules; Correction
199 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model; Correction
200 Medical Devices; Cardiovascular Devices; Classification of the Extracorporeal System for Carbon Dioxide Removal
201 Medical Devices; Orthopedic Devices; Classification of the Resorbable Implant for Anterior Cruciate Ligament (ACL) Repair
202 Medical Devices; Cardiovascular Devices; Classification of the Interventional Cardiovascular Implant Simulation Software Device
203 Medical Devices; Immunology and Microbiology Devices; Classification of the Human Leukocyte Antigen Typing Companion Diagnostic Test
204 Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Hemodynamic Indicator With Decision Point
205 International Dairy Foods Association and Chobani, Inc.: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt; Correction
206 Best Practices for Convening a GRAS Panel; Guidance for Industry; Availability
207 Basic Health Program; Federal Funding Methodology for Program Year 2023 and Changes to the Basic Health Program Payment Notice Process
208 International Dairy Foods Association and Chobani, Inc.: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt
209 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address
210 Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment; Confirmation of Effective Date
211 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-Qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation; Correction
212 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
213 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID-19
214 Requirements for Additional Traceability Records for Certain Foods
215 Medicare and Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Implementing Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs To Provide Refunds With Respect to Discarded Amounts; and COVID-19 Interim Final Rules
216 Clinical Laboratory Improvement Amendments (CLIA) Proficiency Testing Related to Analytes and Acceptable Performance; Correction
217 Listing of Color Additives Exempt From Certification; Spirulina Extract
218 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
219 Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests
220 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-Qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation; Corrections
221 Medicare Program; Calendar Year (CY) 2023 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements; Home Health Value-Based Purchasing Expanded Model Requirements; and Home Infusion Therapy Services Requirements
222 Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and Other Revisions to Medicare Enrollment and Eligibility Rules
223 Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products: Small Entity Compliance Guide; Availability
224 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Supply-Chain Programs and Onsite Audits; Announcement of Effective Date
225 Extension of the Period Before the Food and Drug Administration Intends To Begin Enforcing the Statutory 5 Percent Limit on Out-of-State Distribution of Compounded Human Drug Products
226 Laboratory Accreditation for Analyses of Foods; Small Entity Compliance Guide; Availability
227 Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices
228 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Name and Address
229 Standards for the Electronic Health Record Technology Incentive Program
230 Listing of Color Additives Exempt From Certification; Calcium Carbonate
231 Medicaid Program; Temporary Increase in Federal Medical Assistance Percentage (FMAP) in Response to the COVID-19 Public Health Emergency (PHE); Reopening of Public Comment Period
232 Defining Small Number of Animals for Minor Use Determination; Periodic Reassessment
233 Annual Summary Reporting Requirements Under the Right to Try Act
234 Public Information
235 Listing of Color Additives; of Color Additives Exempt From Certification; Antarctic Krill Meal; Confirmation of Effective Date
236 Food Additives Permitted in Feed and Drinking Water of Animals; Fumonisin Esterase
237 Radiation Oncology (RO) Model
238 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
239 Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products; Guidance for Industry and Food and Drug Administration Staff; Availability
240 Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
241 Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers With Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule; Guidance for Industry; Availability
242 Medicare Program; Suspension of Required Prior Authorization for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items Under Certain Circumstances
243 Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants
244 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-Qualified DeferredCompensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation
245 Food Additives Permitted in Feed and Drinking Water of Animals; Fumonisin Esterase
246 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2023; Changes to the Requirements for the Director of Food and Nutrition Services and Physical Environment Requirements in Long-Term Care Facilities
247 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2023 and Updates to the IRF Quality Reporting Program
248 Medicare Program; FY 2023 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements
249 Medicare Program; FY 2023 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update and Quality Reporting-Request for Information
250 Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
251 Medicare Program; MIPS Payment Adjustment Exception Applicable for Enhancing Oncology Model Monthly Enhanced Oncology Services (MEOS) Payments
252 Clinical Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing Regulations Related to Analytes and Acceptable Performance
253 Survey, Certification, and Enforcement Procedures
254 Medicare Program; Accrediting Organizations-Changes of Ownership; Correction
255 Medical Devices; Cardiovascular Devices; Classification of the Intravascular Bleed Monitor
256 Medical Devices; Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation
257 Medical Devices; Cardiovascular Devices; Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals
258 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
259 Withdrawing Rule on Securing Updated and Necessary Statutory Evaluations Timely
260 Importation of Prescription Drugs Final Rule Questions and Answers; Guidance for Industry: Small Entity Compliance Guide; Availability
261 Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers
262 Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests
263 Medicaid Program; Reassignment of Medicaid Provider Claims
264 Listing of Color Additives Exempt From Certification; Antarctic Krill Meal
265 Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
266 Medical Devices; Cardiovascular Devices; Classification of the Reverse Central Venous Recanalization System
267 Medical Devices; Gastroenterology-Urology Devices; Classification of the Magnetically Maneuvered Capsule Endoscopy System
268 Medical Devices; General and Plastic Surgery Devices; Classification of the Mountable Electromechanical Surgical System for Transluminal Approaches
269 Medicare Program; Accrediting Organizations-Changes of Ownership
270 Medical Devices; General and Plastic Surgery Devices; Classification of the Autofluorescence Detection Device for General Surgery and Dermatological Use
271 Beverages: Bottled Water
272 Medicare Program; Maximum Out-of-Pocket (MOOP) Limits and Service Category Cost Sharing Standards
273 Food Additives Permitted in Feed and Drinking Water of Animals; Methyl Esters of Conjugated Linoleic Acid
274 Food Additives
275 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
276 Medical Devices; Technical Amendments
277 Food Labeling
278 Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4; Guidance for Industry; Availability
279 Advisory Committee; Bone, Reproductive and Urologic Drugs Advisory Committee; Change of Name and Function; Technical Amendment
280 Milk and Cream; Petition for an Administrative Stay of Action: Definitions and Standards of Identity for Yogurt, Lowfat Yogurt, and Nonfat Yogurt
281 Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions; Guidance for Industry; Availability
282 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Interoperable Automated Glycemic Controller
283 Initiation of Voluntary Recalls; Guidance for Industry and Food and Drug Administration Staff; Availability
284 Securing Updated and Necessary Statutory Evaluations Timely; Administrative Delay of Effective Date
285 Medical Devices; Orthopedic Devices; Classification of the Screw Sleeve Bone Fixation Device
286 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
287 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor
288 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Integrated Continuous Glucose Monitoring System
289 Medical Devices; Cardiovascular Devices; Classification of the Percutaneous Catheter for Creation of an Arteriovenous Fistula for Hemodialysis Access
290 Medical Devices; Ophthalmic Devices; Classification of the Electromechanical Tear Stimulator
291 Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Predictive Cardiovascular Indicator
292 Medical Devices; General Hospital and Personal Use Devices; Classification of the Spore Test Strip
293 Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements; Corrections
294 Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Microorganisms and Antimicrobial Resistance Using Reporter Expression
295 Medical Devices; Cardiovascular Devices; Classification of the Photoplethysmograph Analysis Software for Over-the-Counter Use
296 Medical Devices; General and Plastic Surgery Devices; Classification of the Carbon Dioxide Gas Controlled Tissue Expander
297 Medical Devices; General Hospital and Personal Use Devices; Classification of the Alternate Controller Enabled Infusion Pump
298 Laboratory Accreditation for Analyses of Foods; Correction
299 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; Changes to Medicare Graduate Medical Education Payments for Teaching Hospitals; Changes to Organ Acquisition Payment Policies
300 Medical Devices; Ophthalmic Devices; Classification of the Retinal Diagnostic Software Device
301 Medical Devices; Cardiovascular Devices; Classification of the Electrocardiograph Software for Over-the-Counter Use
302 New Method for the Analysis of Sulfites in Foods
303 Medicare Program; Updates to Lists Related to Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Conditions of Payment
304 French Dressing; Revocation of a Standard of Identity
305 Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications
306 Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater
307 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model; Correction
308 Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas
309 Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract; Confirmation of Effective Date
310 Listing of Color Additives Exempt From Certification; Silver Nitrate; Confirmation of Effective Date
311 Medical Devices; Gastroenterology-Urology Devices; Classification of the Transcutaneous Electrical Continence Device
312 Medical Devices; Neurological Devices; Classification of the Diagnostic Neurosurgical Microscope Filter
313 Medical Devices; Neurological Devices; Classification of the Cerebrospinal Fluid Shunt System
314 Most Favored Nation (MFN) Model
315 Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas
316 Medical Devices; Anesthesiology Devices; Classification of the Retrograde Intubation Device
317 Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; Provider and Supplier Prepayment and Post-Payment Medical Review Requirements; Correction
318 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals; Changes to Medicare Graduate Medical Education Payments for Teaching Hospitals; Changes to Organ Acquisition Payment Policies
319 Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities; Correction
320 Medical Devices; General and Plastic Surgery Devices; Classification of the Manual Percutaneous Surgical Set Assembled in the Abdomen
321 Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States; Correction
322 Medical Devices; Neurological Devices; Classification of the Traumatic Brain Injury Eye Movement Assessment Aid
323 Medical Devices; Gastroenterology-Urology Devices; Classification of the Nonimplanted Nerve Stimulator for Functional Abdominal Pain Relief
324 Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Transhepatic Venous Access Needle
325 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model; Correction
326 Medical Devices; Neurological Devices; Classification of the Temporary Coil Embolization Assist Device
327 Medical Devices; Gastroenterology-Urology Devices; Classification of the Pressure Ulcer Management Tool
328 Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organizations and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers
329 Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingested, Transient, Space Occupying Device for Weight Management and/or Weight Loss
330 Medical Devices; General and Plastic Surgery Devices; Classification of the Negative Pressure Wound Therapy Device for Reduction of Wound Complications
331 Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator for Attention Deficit Hyperactivity Disorder
332 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
333 Medical Devices; Exemption From Premarket Notification: Powered Patient Transport, All Other Powered Patient Transport
334 Laboratory Accreditation for Analyses of Foods
335 Medical Devices; Anesthesiology Devices; Classification of the Isocapnic Ventilation Device
336 Medical Devices; Gastroenterology-Urology Devices; Classification of the Esophageal Tissue Characterization System
337 Medical Devices; Neurological Devices; Classification of the Trunk and Limb Electrical Stimulator To Treat Headache
338 Medical Devices; Neurological Devices; Classification of the Conditioning Tool for Eating Disorders
339 Medical Devices; Orthopedic Devices; Classification of the Intraoperative Orthopedic Strain Sensor
340 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program; Correction
341 Medical Devices; General and Plastic Surgery Devices; Classification of the General Laparoscopic Power Morcellation Containment System
342 Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, Renamed to Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
343 Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests
344 Effective Date of Requirement for Premarket Approval for Blood Lancets
345 Medical Devices; General and Plastic Surgery Devices; Reclassification of Blood Lancets
346 Medicare Program; Opioid Treatment Programs: CY 2022 Methadone Payment Exception
347 Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States
348 Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-Payment Medical Review Requirements
349 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model
350 Adjustment of Civil Monetary Penalties for Inflation and the Annual Civil Monetary Penalties Inflation Adjustment for 2021
351 Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
352 Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities
353 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsor Address
354 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model
355 Medicare and Medicaid Programs; Omnibus COVID-19 Health Care Staff Vaccination
356 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
357 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program; Corrections
358 Termination of Listing of Color Additives Exempt From Certification; Lead Acetate
359 General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
360 Listing of Color Additives Exempt From Certification; Silver Nitrate
361 Premarket Tobacco Product Applications and Recordkeeping Requirements
362 Medical Device De Novo Classification Process
363 Content and Format of Substantial Equivalence Reports; Food and Drug Administration Actions on Substantial Equivalence Reports
364 Medicare Program; Fiscal Year (FY) 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022); Correction
365 Import Tolerances for Residues of Unapproved New Animal Drugs in Food
366 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
367 Medicare and Medicaid Programs; Adjustment of Civil Monetary Penalties for Inflation; Continuation of Effectiveness and Extension of Timeline for Publication of the Final Rule
368 Revision to Restrictions on Shipment or Use for Human Blood and Blood Components Exceptions; Technical Amendment
369 Listing of Color Additives Exempt From Certification; Butterfly Pea Flower Extract
370 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program
371 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2022 and Updates to the IRF Quality Reporting Program; Payment for Complex Rehabilitative Wheelchairs and Related Accessories (Including Seating Systems) and Seat and Back Cushions Furnished in Connection With Such Wheelchairs
372 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2022; and Technical Correction to Long-Term Care Facilities Physical Environment Requirements
373 Medicare Program; FY 2022 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, Hospice and Home Health Quality Reporting Program Requirements
374 Medicare Program; FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)
375 Regulations Regarding “Intended Uses”
376 Medicare Program; Calendar Year 2021 Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants
377 Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue
378 Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid
379 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
380 Medicare Program: Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes to Episode Definition and Pricing; Medicare and Medicaid Programs; Policies and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
381 Basic Health Program; Federal Funding Methodology for Program Year 2022
382 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-Owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots, Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) To Report COVID-19 Therapeutic Inventory and Usage and To Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19)
383 Medicare Program: Comprehensive Care for Joint Replacement Model Three Year Extension and Changes to Episode Definition and Pricing; Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Correction
384 Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt
385 Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All Inclusive Care for the Elderly; Corrections
386 Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date
387 Medicare and Medicaid Programs; COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals With Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff
388 Medicare Program; Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board (MGCRB)
389 Medicare Program: Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes to Episode Definition and Pricing; Medicare and Medicaid Programs; Policies and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
390 Medicare Program; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas; Extension of Timeline for Final Rule Publication
391 Medical Devices; Medical Device Classification Regulations To Conform to Medical Software Provisions in the 21st Century Cures Act
392 Electronic Import Entries; Technical Amendments
393 New Animal Drugs; Approval of New Animal Drug Applications
394 Medical Devices; Technical Amendments
395 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Corrections
396 Securing Updated and Necessary Statutory Evaluations Timely; Administrative Delay of Effective Date; Correction
397 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address
398 Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-In Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions From the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19; Correction
399 Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”; Delay of Effective Date; Public Comment Period
400 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor
401 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-Owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic Inventory and Usage and To Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19); Correction
402 New Animal Drug Applications; Beta-Aminopropionitrile Fumarate; n-Butyl Chloride; Cupric Glycinate Injection; Dichlorophene and Toluene; Orgotein for Injection; Tetracycline Tablets
403 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
404 Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-In Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions From the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19; Correcting Amendment
405 Medicare Program; Secure Electronic Prior Authorization for Medicare Part D Program; Delay in Effective Date
406 Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations; Public Comment Period; Delay of Effective Date
407 Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-In Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions From the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19; Correction
408 Securing Updated and Necessary Statutory Evaluations Timely
409 Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly
410 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
411 Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of “Reasonable and Necessary”
412 Uniform Compliance Date for Food Labeling Regulations
413 Medicare Program; Secure Electronic Prior Authorization For Medicare Part D
414 Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements
415 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-Owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots, Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) To Report COVID-19 Therapeutic Inventory and Usage and To Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19)
416 Medicare Program; CY 2021 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-in Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions from the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19
417 The Use of an Alternate Name for Potassium Chloride in Food Labeling; Guidance for Industry; Availability
418 Regulatory Clean Up Initiative; Correction
419 Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants-Update
420 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals; Correction
421 Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures; Correction
422 Medicare Program; Modernizing and Clarifying the Physician Self-Referral Regulations
423 Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations
424 Amendments to the HHS-Operated Risk Adjustment Data Validation (HHS-RADV) Under the Patient Protection and Affordable Care Act's HHS-Operated Risk Adjustment Program
425 Most Favored Nation (MFN) Model
426 Regulatory Clean Up Initiative
427 Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care
428 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program
429 Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
430 Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate Update, Home Health Quality Reporting Program Requirements, and Home Infusion Therapy Services and Supplier Enrollment Requirements; and Home Health Value-Based Purchasing Model Data Submission Requirements
431 The Declaration of Allulose and Calories From Allulose on Nutrition and Supplement Facts Labels; Availability
432 Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants; Correction
433 Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program; Correction
434 Importation of Prescription Drugs
435 Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures
436 Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements; Correction
437 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals
438 Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Billing Information for Qualifying APM Participants
439 Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Correction
440 Medicare and Medicaid Programs; Adjustment of Civil Monetary Penalties for Inflation; Continuation of Effectiveness and Extension of Timeline for Publication of the Final Rule
441 Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
442 Medicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements; Correcting Amendment
443 Medicare Program; FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021); Correction
444 Revocation of the Test for Mycoplasma
445 Medical Devices; Petition for an Administrative Stay of Action: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
446 Office of Regulatory Affairs Division Director; Technical Amendments
447 Veterinary Feed Directive Drugs; Contact Information
448 Basic Health Program; Federal Funding Methodology for Program Year 2021
449 Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods
450 Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
451 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2021
452 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Value-Based Purchasing Program for Federal Fiscal Year 2021
453 Medicare Program; FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)
454 Medicare Program; FY 2021 Hospice Wage Index and Payment Rate Update
455 Postmarketing Safety Reports for Approved New Animal Drugs; Electronic Submission Requirements
456 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor
457 New Animal Drugs; Withdrawal of Approval of Abbreviated New Animal Drug Application
458 Medical Devices; Exemptions From Premarket Notification: Class II Devices
459 Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; Availability
460 Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 Mushroom Powder
461 Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability
462 Nondiscrimination in Health and Health Education Programs or Activities, Delegation of Authority
463 Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption From the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: Guidance for Industry; Availability
464 Food Additives Permitted in Feed and Drinking Water of Animals; Silicon Dioxide
465 Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program
466 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements; Delayed Effective Date
467 Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program
468 Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide; Availability
469 Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Interoperability and Patient Access for Medicare Advantage Organization and Medicaid Managed Care Plans, State Medicaid Agencies, CHIP Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, and Health Care Providers
470 Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency: Guidance for Industry; Availability
471 Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
472 Medical Devices; Technical Amendments
473 Medical Devices; Technical Amendment
474 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsors' Name and Addresses
475 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
476 Temporary Policy Regarding Preventive Controls and Foreign Supplier Verification Programs Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry; Availability
477 Office of Regulatory Affairs Division Director; Technical Amendments
478 Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide; Guidance for Industry; Availability
479 Tobacco Products; Required Warnings for Cigarette Packages and Advertisements
480 Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
481 Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
482 Definition of the Term “Biological Product”
483 Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Correcting Amendment
484 Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment
485 Medical Devices; Immunology and Microbiology Devices; Classification of Human Immunodeficiency Virus Drug Resistance Genotyping Assay Using Next Generation Sequencing Technology
486 Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Small Entity Compliance Guide; Availability
487 Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants; Confirmation of Effective Date
488 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsor; Change of Sponsor's Address
489 New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application; Withdrawal of Approval of Abbreviated New Animal Drug Applications
490 Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer
491 Medical Devices; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software
492 Radiology Devices; Reclassification of Medical Image Analyzers
493 Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Wheeled Stretcher
494 Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Correction
495 Medicare and Medicaid Programs; Adjustment of Civil Monetary Penalties for Inflation; Continuation of Effectiveness and Extension of Timeline for Publication of the Final Rule
496 Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine Interim Final Rule; Correction
497 Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics; Guidance for Industry; Availability
498 Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
499 Medicare Program; Advanced Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians-Request for Current Banking Information for Qualifying APM Participants
500 Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Devices Intended To Treat Anxiety and/or Insomnia; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Devices Intended To Treat Depression
501 Listing of Color Additives Exempt From Certification; Soy Leghemoglobin
502 Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
503 Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format
504 Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States
505 Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine Interim Final Rule
506 Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots
507 Medicare and Medicaid Programs; CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements
508 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Fee Schedule Amounts, DMEPOS Competitive Bidding Program (CBP) Amendments, Standard Elements for a DMEPOS Order, and Master List of DMEPOS Items Potentially Subject to a Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements
509 Basic Health Program; Federal Funding Methodology for Program Years 2019 and 2020
510 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System
511 Medical Devices; Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid
512 Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size
513 Medical Devices; Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants With Press-Fit Fixation
514 Medical Devices; Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic Massager
515 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals; Correction
516 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Name and Address
517 Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Fire Safety Requirements for Certain Dialysis Facilities; Hospital and Critical Access Hospital (CAH) Changes To Promote Innovation, Flexibility, and Improvement in Patient Care
518 Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care
519 Medicaid Program; State Disproportionate Share Hospital Allotment Reductions
520 Medicare, Medicaid, and Children's Health Insurance Programs; Program Integrity Enhancements to the Provider Enrollment Process
521 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals
522 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsors' Names and Addresses
523 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
524 Medicare Program; Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year 2020 and Updates to the IRF Quality Reporting Program
525 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2020
526 Medicare Program; FY 2020 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2019 (FY 2020)
527 Medicare Program; FY 2020 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements
528 Listing of Color Additives Exempt From Certification; Soy Leghemoglobin
529 Medicare and Medicaid Programs; Revision of Requirements for Long-Term Care Facilities: Arbitration Agreements
530 New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food
531 Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency; Immediately in Effect Guidance for Industry; Availability
532 Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health
533 Determining the Number of Employees for Purposes of the “Small Business” Definition (Current Good Manufacturing Practices and Preventive Controls Regulations for Human and Animal Food): Guidance for Industry; Availability
534 The Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products; Guidance for Industry; Availability
535 Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems; Guidance for Industry; Availability
536 Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021; Correction
537 Medicare Program; Explanation of Federal Fiscal Year (FY) 2004, 2005, and 2006 Outlier Fixed-Loss Thresholds as Required by Court Rulings
538 Medicare and Medicaid Programs; Programs of All-Inclusive Care for the Elderly (PACE)
539 Section 503A Bulks List Final Rule Questions and Answers; Guidance for Industry; Small Entity Compliance Guide; Availability
540 Modernizing Part D and Medicare Advantage To Lower Drug Prices and Reduce Out-of-Pocket Expenses
541 Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I; Correction
542 Home Health Services
543 Medicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency
544 Medicare Program; Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures
545 Medicaid Program; Reassignment of Medicaid Provider Claims
546 Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability
547 Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment
548 Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary Utilization
549 Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide; Confirmation of Effective Date
550 Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021
551 Medical Devices; Anesthesiology Devices; Classification of the Ventilatory Electrical Impedance Tomograph
552 Medical Devices; Classification of Accessories Distinct From Other Devices; Finalized List of Accessories Suitable for Class I
553 Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
554 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
555 Implementing the Food and Drug Administration Food Safety Modernization Act; Technical Amendment
556 Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products
557 Reinstatement of Color Additive Listing for Lead Acetate
558 Medical Devices; Technical Amendment
559 Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection
560 Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems
561 Medicaid Program; Covered Outpatient Drug; Line Extension Definition; and Change to the Rebate Calculation for Line Extension Drugs
562 Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds; Guidance for Industry; Availability
563 Medicaid; Revisions to State Medicaid Fraud Control Unit Rules
564 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E
565 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program-Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program-Accountable Care Organizations-Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; Correction
566 Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microorganisms and Associated Resistance Marker Nucleic Acids Directly in Respiratory Specimens
567 Medical Devices; Neurological Devices; Classification of the Transcranial Magnetic Stimulation System for Neurological and Psychiatric Disorders and Conditions
568 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
569 New Animal Drugs; Withdrawal of Approval of New Animal Drug Application
570 Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue
571 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Software Application for Contraception
572 Change of Address; Technical Amendment
573 Food Additives Permitted in Feed and Drinking Water of Animals; Gamma-Linolenic Acid Safflower Oil
574 Medical Devices; Dental Devices; Classification of the Auto Titration Device for Oral Appliances
575 List of Bulk Drug Substances That Can Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act
576 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program-Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program-Accountable Care Organizations Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act; Correction
577 Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Pathways to Success and Extreme and Uncontrollable Circumstances Policies for Performance Year 2017
578 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS; Correction
579 Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction
580 Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid
581 Neurological Devices; Reclassification of Electroconvulsive Therapy Devices; Effective Date of Requirement for Premarket Approval for Electroconvulsive Therapy Devices for Certain Specified Intended Uses
582 Food Labeling; Revision of the Nutrition and Supplement Facts Labels; Technical Amendments
583 Uniform Compliance Date for Food Labeling Regulations
584 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
585 Listing of Color Additives Subject to Certification; D&C Yellow No. 8; Confirmation of Effective Date
586 Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures
587 List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
588 Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction
589 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program-Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program-Accountable Care Organizations-Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act
590 Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
591 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS
592 Sensient Colors, LLC; Filing of Color Additive Petition
593 Medicare and Medicaid Programs; CY 2019 Home Health Prospective Payment System Rate Update and CY 2020 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; Home Infusion Therapy Requirements; and Training Requirements for Surveyors of National Accrediting Organizations
594 Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Guidance for Industry; Availability
595 Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies; Extension of Timeline for Publication of Final Rule
596 Listing of Color Additives Exempt From Certification; Synthetic Iron Oxide
597 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Insulin Therapy Adjustment Device
598 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Meprobamate Test System
599 Termination of Listing of Color Additive Exempt From Certification; Lead Acetate
600 Medical Devices; Anesthesiology Devices; Classification of the High Flow Humidified Oxygen Delivery Device
601 Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System
602 Medical Devices; Anesthesiology Devices; Classification of the Positive Airway Pressure Delivery System
603 Medical Devices; General and Plastic Surgery Devices; Classification of the Wound Autofluorescence Imaging Device
604 Medical Devices; General and Plastic Surgery Devices; Classification of the Light Based Energy Source Device for Topical Application
605 Medical Devices; General and Plastic Surgery Devices; Classification of the Hemostatic Device for Intraluminal Gastrointestinal Use
606 Medical Devices; Neurological Devices; Classification of the Thermal Vestibular Stimulator for Headache
607 Medical Devices; Ophthalmic Devices; Classification of the Intranasal Electrostimulation Device for Dry Eye Symptoms
608 Medical Devices; Immunology and Microbiology Devices; Classification of the Herpes Virus Nucleic Acid-Based Cutaneous and Mucocutaneous Lesion Panel
609 Medical Devices; Neurological Devices; Classification of the External Upper Limb Tremor Stimulator
610 Food Additives Permitted for Direct Addition to Food for Human Consumption; Styrene
611 Food Additive Regulations; Synthetic Flavoring Agents and Adjuvants
612 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Final Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting Program; Correction
613 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims; Correction
614 Food Additives Permitted in Feed and Drinking Water of Animals; 25-Hydroxyvitamin D3
615 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name
616 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
617 Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom
618 Listing of Color Additives Subject to Certification; D&C Yellow No. 8
619 Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3
620 Listing of Color Additives Subject to Certification; D&C Black No. 4; Confirmation of Effective Date
621 Determination of Status as a Qualified Facility Under the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules; Guidance for Industry; Availability
622 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
623 Medicare Program; Certain Changes to the Low-Volume Hospital Payment Adjustment Under the Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals for Fiscal Years 2011 Through 2017
624 Questions and Answers Regarding Food Facility Registration (Seventh Edition); Guidance for Industry; Availability
625 Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of Revisions to the Provider Enrollment Moratoria Access Waiver Demonstration for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Moratoria-Designated Geographic Locations
626 Medical Devices and Device-Led Combination Products; Voluntary Malfunction Summary Reporting Program for Manufacturers
627 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims
628 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Final Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting Program
629 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019
630 Medicare Program; FY 2019 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2018 (FY 2019)
631 Medicare Program; FY 2019 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements
632 Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
633 Antimicrobial Animal Drug Sales and Distribution Reporting; Small Entity Compliance Guide; Availability
634 Medical Devices; Immunology and Microbiology Devices; Classification of the Next Generation Sequencing Based Tumor Profiling Test
635 Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal
636 The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; Availability
637 Medicare Program; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction
638 Medical Devices; Immunology and Microbiology Devices; Classification of the Brain Trauma Assessment Test
639 Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System
640 Medical Devices; Orthopedic Devices; Classification of the In Vivo Cured Intramedullary Fixation Rod
641 Medical Devices; General and Plastic Surgery Devices; Classification of the Microneedling Device for Aesthetic Use
642 Medicare Program; Changes to the Comprehensive Care for Joint Replacement Payment Model (CJR): Extreme and Uncontrollable Circumstances Policy for the CJR Model
643 Listing of Color Additives Subject to Certification; D&C Black No. 4
644 Medical Devices; Exemptions From Premarket Notification: Class II Devices
645 Medicare Program; Update to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items That Require Prior Authorization as a Condition of Payment
646 Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year; Corrections
647 Final Determination Regarding Partially Hydrogenated Oils
648 Medical Devices; Hematology and Pathology Devices; Classification of Blood Establishment Computer Software and Accessories
649 Medical Devices; Exemption From Premarket Notification: Class II Devices; Surgical Apparel
650 The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
651 Medicare Program; Durable Medical Equipment Fee Schedule Adjustments To Resume the Transitional 50/50 Blended Rates To Provide Relief in Rural Areas and Non-Contiguous Areas
652 Menu Labeling: Supplemental Guidance for Industry; Availability
653 Food Additives Permitted in Feed and Drinking Water of Animals; Marine Microalgae
654 Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products; Withdrawal
655 General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
656 Food Labeling: Revision of the Nutrition and Supplement Facts Labels and Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments; Extension of Compliance Dates
657 Crabmeat; Amendment of Common or Usual Name Regulation
658 Medicaid/CHIP Program; Medicaid Program and Children's Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care Act; Correction
659 Managed Care
660 Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program
661 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
662 Medical Devices; Technical Amendment
663 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
664 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
665 Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items; Update to the Master List of Items Frequently Subject to Unnecessary Utilization
666 Good Guidance Practices; Technical Amendment
667 Cigarettes, Smokeless Tobacco, and Covered Tobacco Products; Change of Office Name and Address; Technical Amendment
668 Revision of Organization; Technical Amendment
669 Application of the Foreign Supplier Verification Program Regulation to the Importation of Live Animals: Guidance for Industry; Availability
670 Immediately in Effect Guidance for Industry; Compliance Policy for Combination Product Postmarketing Safety Reporting; Availability
671 Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Partial Delay of Effective Date
672 Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems; Correction
673 Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit
674 Medical Devices; General and Plastic Surgery Devices; Classification of the Extracorporeal Shock Wave Device for Treatment of Chronic Wounds
675 Food Additives Permitted in Feed and Drinking Water of Animals; Silicon Dioxide as a Carrier for Flavors
676 Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems
677 Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices
678 Medical Devices; General and Plastic Surgery Devices; Classification of the Non-Absorbable, Hemostatic Gauze for Temporary Internal Use
679 Medical Devices; Neurological Devices; Classification of the Percutaneous Nerve Stimulator for Substance Use Disorders
680 Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date
681 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
682 Medical Devices; Cardiovascular Devices; Classification of the Temporary Catheter for Embolic Protection During Transcatheter Intracardiac Procedures
683 Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
684 Medical Devices; General and Plastic Surgery Devices; Classification of the Surgical Smoke Precipitator
685 Removal of Certain Time of Inspection and Duties of Inspector Regulations for Biological Products
686 Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability
687 Medical Devices; Radiology Devices; Classification of the Absorbable Perirectal Spacer
688 Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs; Guidance for Industry; Availability
689 Medical Devices; Hematology and Pathology Devices; Classification of a Cervical Intraepithelial Neoplasia Test System
690 Food Additives Permitted in Feed and Drinking Water of Animals; Formic Acid as a Feed Acidifying Agent in Complete Poultry Feeds
691 Medical Devices; Hematology and Pathology Devices; Classification of the Whole Slide Imaging System
692 Medical Devices; General and Plastic Surgery Devices; Classification of the Irrigating Wound Retractor Device
693 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Pressure Wedge for the Reduction of Cesarean Delivery
694 New Animal Drugs for Investigational Use; Disqualification of a Clinical Investigator
695 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Reagents for Molecular Diagnostic Instrument Test Systems
696 Medical Devices; Hematology and Pathology Devices; Classification of the Flow Cytometric Test System for Hematopoietic Neoplasms
697 Medical Devices; Neurological Devices; Classification of the Computerized Behavioral Therapy Device for Psychiatric Disorders
698 Medical Devices; Neurological Devices; Classification of the External Vagal Nerve Stimulator for Headache
699 Medical Devices; Radiology Devices; Classification of the Rectal Balloon for Prostate Immobilization
700 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction
701 Medical Devices; Anesthesiology Devices; Classification of the External Negative Pressure Airway Aid
702 Medicare Program; Medicare Shared Savings Program: Extreme and Uncontrollable Circumstances Policies for Performance Year 2017
703 Medical Devices; General Hospital and Personal Use Devices; Classification of the Image Processing Device for Estimation of External Blood Loss
704 Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
705 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Fetal Head Elevator
706 Medical Devices; Ophthalmic Devices; Classification of the Tear Electrostimulation Device
707 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
708 Advisory Committee; Food Advisory Committee; Termination
709 New Animal Drugs; Approval of New Animal Drug Applications
710 Medicare Program; Cancellation of Advancing Care Coordination Through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model: Extreme and Uncontrollable Circumstances Policy for the Comprehensive Care for Joint Replacement Payment Model
711 Sanitary Transportation of Human and Animal Food: What You Need to Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
712 Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability
713 Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff; Availability
714 Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year
715 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program
716 Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostatic Artery Embolization Device
717 Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Indirect Immunofluorescence Microscope and Software-Assisted System
718 Food Additives Permitted in Feed and Drinking Water of Animals; Ammonium Formate and Formic Acid
719 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
720 Listing of Color Additives Exempt From Certification; Calcium Carbonate
721 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System
722 Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System
723 Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System
724 Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements
725 Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food: Guidance for Industry; Availability
726 Medical Devices; Immunology and Microbiology Devices; Classification of the BCR-ABL Quantitation Test
727 Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program
728 Medical Devices; Immunology and Microbiology Devices; Classification of the Streptococcus SPP. Nucleic Acid-Based Assay
729 Medical Devices; Immunology and Microbiology Devices; Classification of the Newborn Screening Test for Severe Combined Immunodeficiency Disorder
730 Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss
731 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Acute Kidney Injury Test System
732 Medical Devices; Neurological Devices; Classification of the Non-Electroencephalogram Physiological Signal Based Seizure Monitoring System
733 Medical Devices; Immunology and Microbiology Devices; Classification of the Aquaporin-4 Autoantibody Immunological Test System
734 Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Measure Non-Microbial Analyte(s) in Human Clinical Specimens To Aid in Assessment of Patients With Suspected Sepsis
735 Medical Devices; Immunology and Microbiology Devices; Classification of the Mass Spectrometer System for Clinical Use for the Identification of Microorganisms
736 Medical Devices; Immunology and Microbiology Devices; Classification of the Zinc Transporter 8 Autoantibody Immunological Test System
737 Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect and Identify Microbial Pathogen Nucleic Acids in Cerebrospinal Fluid
738 Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing
739 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Organophosphate Test System
740 Medical Devices; Immunology and Microbiology Devices; Classification of the Nucleic Acid-Based Device for the Amplification, Detection, and Identification of Microbial Pathogens Directly From Whole Blood Specimens
741 Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Image Assessment System for Microbial Colonies on Solid Culture Media
742 Medical Devices; Gastroenterology-Urology Devices; Classification of the Enzyme Packed Cartridge
743 Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device; Correction
744 Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator; Correction
745 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices; Correction
746 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Correction of the Performance Period for the NHSN HCP Influenza Vaccination Immunization Reporting Measure in the ESRD QIP for PY 2020; Correction
747 Medical Devices; Gastroenterology-Urology Devices; Classification of the High Intensity Ultrasound System for Prostate Tissue Ablation
748 Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date
749 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
750 Adjustment of Civil Monetary Penalties for Inflation; Correcting Amendment
751 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability
752 Mitigation Strategies To Protect Food Against Intentional Adulteration: What You Need To Know About the Food and Drug Administration Regulation: Small Entity Compliance Guide; Availability
753 Medical Device Classification Procedures; Change of Address; Technical Amendment
754 Food Additives Permitted in Feed and Drinking Water of Animals; Gamma-Linolenic Acid Safflower Oil
755 Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry; Availability
756 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2018 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Program Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Provider-Based Status of Indian Health Service and Tribal Facilities and Organizations; Costs Reporting and Provider Requirements; Agreement Termination Notices
757 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2018, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, Survey Team Composition, and Correction of the Performance Period for the NHSN HCP Influenza Vaccination Immunization Reporting Measure in the ESRD QIP for PY 2020
758 Medicare Program; FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements
759 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2018
760 Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator
761 Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss
762 Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device
763 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Closed Loop Hysteroscopic Insufflator With Cutter-Coagulator
764 Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations
765 Medical Devices; Immunology and Microbiology Devices; Classification of the Assayed Quality Control Material for Clinical Microbiology Assays
766 Medical Devices; Cardiovascular Devices; Classification of the Balloon Aortic Valvuloplasty Catheter
767 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period; Correction
768 Civil Money Penalty Definitions; Technical Amendment
769 Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities
770 Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies; Delay of Effective Date
771 Medicaid/CHIP Program; Medicaid Program and Children's Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care Act
772 Waivers From Requirements of the Sanitary Transportation of Human and Animal Food Rule; Correction
773 Listing of Color Additives Exempt From Certification; Spirulina Extract
774 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period
775 Humanitarian Use Devices; 21st Century Cures Act; Technical Amendment
776 Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR); Delay of Effective Date
777 Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments; Extension of Comment Period
778 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
779 New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
780 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date; Request for Comments
781 Indirect Food Additives: Polymers
782 Waivers From Requirements of the Sanitary Transportation of Human and Animal Food Rule
783 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital; Correcting Amendment
784 Medicaid Program; Disproportionate Share Hospital Payments-Treatment of Third Party Payers in Calculating Uncompensated Care Costs
785 Requirements To Submit Prior Notice of Imported Food; Technical Amendments
786 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements; Corrections
787 Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model; Delay of Effective Date
788 Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments
789 Presiding Officer for an Appeal and Informal Hearing; Technical Amendments
790 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Secondary Display
791 Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the High Throughput Genomic Sequence Analyzer for Clinical Use
792 Medical Devices; Neurological Devices, Classification of the Vibratory Counter-Stimulation Device
793 Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Corrections
794 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Name
795 New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
796 Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories
797 Use of Ozone-Depleting Substances
798 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of a New Animal Drug Application; Change of Sponsor; Change of Sponsor's Address
799 New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
800 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
801 New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
802 Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model; Delay of Effective Date
803 Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Delayed Effective Date
804 Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Revised Effective Date
805 Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper; Confirmation of Effective Date
806 Medicaid Program; The Use of New or Increased Pass-Through Payments in Medicaid Managed Care Delivery Systems
807 Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures
808 Cardiovascular Devices
809 Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies
810 Microbiology Devices; Reclassification of Influenza Virus Antigen Detection Test Systems Intended for Use Directly With Clinical Specimens
811 Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems
812 Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
813 Obstetrical and Gynecological Devices; Reclassification of Surgical Instrumentation for Use With Urogynecologic Surgical Mesh
814 Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Corrections
815 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital; Correction and Extension of Comment Period
816 Medicare Program; Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)
817 Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems
818 Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date
819 Refuse To Accept Procedures for Premarket Tobacco Product Submissions
820 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements; Corrections
821 Oral Dosage Form New Animal Drugs; Approval of New Animal Drug Applications
822 New Animal Drugs for Use in Animal Feed; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications
823 New Animal Drugs; Withdrawal of Approval of New Animal Drug Applications
824 Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate
825 Medical Devices; Neurological Devices; Classification of the Neurovascular Mechanical Thrombectomy Device for Acute Ischemic Stroke Treatment
826 Medicare Program; End-Stage Renal Disease Quality Incentive Program; Durable Medical Equipment, Prosthetics, Orthotics, and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure, and Appeals Process for Breach of Contract Actions; Correction
827 Medicare Program; Implementation of Prior Authorization Process for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items and Publication of the Initial Required Prior Authorization List of DMEPOS Items That Require Prior Authorization as a Condition of Payment
828 Postmarketing Safety Reporting for Combination Products
829 Flexibility, Efficiency, and Modernization in Child Support Enforcement Programs
830 General Hospital and Personal Use Devices: Renaming of Pediatric Hospital Bed Classification and Designation of Special Controls for Pediatric Medical Crib; Classification of Medical Bassinet
831 Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease
832 Banned Devices; Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove
833 Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program
834 Medicare Program; Conditions for Coverage for End-Stage Renal Disease Facilities-Third Party Payment
835 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
836 Third-Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards; Guidance for Industry and Food and Drug Administration Staff; Availability
837 Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid for Concussion
838 Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid
839 Medicaid and Children's Health Insurance Programs: Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Other Provisions Related to Eligibility and Enrollment for Medicaid and CHIP
840 New Animal Drugs for Use in Animal Feed; Category Definitions; Confirmation of Effective Date
841 Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
842 Uniform Compliance Date for Food Labeling Regulations
843 Food Labeling
844 Food Labeling
845 Food Labeling
846 Food and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
847 Indirect Food Additives: Paper and Paperboard Components
848 Medical Gas Containers and Closures; Current Good Manufacturing Practice Requirements
849 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements
850 Refuse To Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal
851 Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers; Correction
852 Medicaid Program; Covered Outpatient Drug; Delay in Change in Definitions of States and United States
853 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements
854 Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates Under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital
855 Amendments to Regulations on Citizen Petitions, Petitions for Stay of Action, and Submission of Documents to Dockets
856 Revision of Organization and Conforming Changes to Regulation
857 Medicare Program; Merit-Based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive Under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models
858 Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model
859 Medicare and Medicaid Programs; CY 2017 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements
860 Listing of Color Additives Exempt From Certification; Titanium Dioxide and Listing of Color Additives Subject to Certification; [Phthalocyaninato (2-)] Copper
861 What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Small Entity Compliance Guide; Availability
862 What You Need To Know About the Food and Drug Administration Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Small Entity Compliance Guide; Availability
863 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals; Correction
864 Use of Ozone-Depleting Substances
865 Medical Devices; Ear, Nose, and Throat Devices; Classification of the Eustachian Tube Balloon Dilation System
866 Medical Devices; Physical Medicine Devices; Classification of the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder With Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components
867 Medical Devices; Cardiovascular Devices; Classification of the Apical Closure Device
868 Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings; Correction
869 Medical Devices; Custom Devices; Technical Amendment
870 Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness
871 Abbreviated New Drug Applications and 505(b)(2) Applications
872 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals; Correction
873 Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
874 Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format
875 Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities
876 New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor's Address
877 Food Additives Permitted in Feed and Drinking Water of Animals; Feed Grade Sodium Formate
878 Medical Devices; Neurological Devices; Classification of the Evoked Photon Image Capture Device
879 Use of the Term “Healthy” in the Labeling of Human Food Products: Guidance for Industry; Availability
880 Medical Devices; Ophthalmic Devices; Classification of Strabismus Detection Device
881 Medical Devices; General and Plastic Surgery Devices; Classification of the Magnetic Surgical Instrument System
882 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Definition of Qualified Auditor; Announcement of Effective Date
883 Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers
884 New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline, Procaine Penicillin, and Sulfamethazine
885 Maximum Civil Money Penalty Amounts; Technical Amendment
886 Substances Generally Recognized as Safe
887 Adjustment of Civil Monetary Penalties for Inflation
888 Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
889 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017; Correction
890 Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs
891 Food Labeling; Technical Amendments
892 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship; Change of Sponsor's Name and Address; Change of Sponsor's Address
893 New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application
894 New Animal Drugs for Use in Animal Feed; Category Definitions
895 The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules
896 Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals
897 Substances Generally Recognized as Safe
898 Calorie Labeling of Articles of Food in Vending Machines: Guidance for Industry; Small Entity Compliance Guide; Availability
899 Calorie Labeling of Articles of Food in Vending Machines; Draft Guidance for Industry; Availability
900 Regulatory Hearing Before the Food and Drug Administration; General Provisions; Technical Amendment
901 New Animal Drug Applications; Contents of Notice of Opportunity for a Hearing; Correction
902 Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products; Confirmation of Effective Date
903 Refuse To Accept Procedures for Premarket Tobacco Product Submissions
904 Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities for FY 2017, SNF Value-Based Purchasing Program, SNF Quality Reporting Program, and SNF Payment Models Research
905 Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017
906 Medicare Program; FY 2017 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements
907 Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Provider Enrollment Moratoria Access Waiver Demonstration of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Moratoria-Designated Geographic Locations
908 Medicare, Medicaid, and Children's Health Insurance Programs: Announcement of the Implementation and Extension of Temporary Moratoria on Enrollment of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in Designated Geographic Locations and Lifting of the Temporary Moratoria on Enrollment of Part B Emergency Ground Ambulance Suppliers in All Geographic Locations
909 Food Labeling; Calorie Labeling of Articles of Food in Vending Machines; Extension of Compliance Date
910 Change of Address; Technical Amendment
911 New Animal Drugs; Change of Sponsor
912 Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes
913 Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date
914 Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Correcting Amendment
915 Emergency Permit Control Regulations; Technical Amendments
916 Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 and Vitamin D3
917 Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972; Technical Amendment
918 Amendments to Registration of Food Facilities
919 Medical Devices; Gastroenterology-Urology Devices; Classification of the Metallic Biliary Stent System for Benign Strictures
920 Medical Devices; Neurological Devices; Classification of the Thermal System for Insomnia
921 Medicare Program: Expanding Uses of Medicare Data by Qualified Entities
922 The Food and Drug Administration's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels; Guidance for Industry; Availability
923 Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities; Correction
924 Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use
925 Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate; Extension of the Comment Period
926 Medicare Program; Medicare Clinical Diagnostic Laboratory Tests Payment System
927 Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
928 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Gynecologic Laparoscopic Power Morcellation Containment System
929 Prior Notice of Imported Food Questions and Answers (Edition 3); Guidance for Industry; Availability
930 Use of Symbols in Labeling
931 Medical Devices; Ophthalmic Devices; Classification of Nasolacrimal Compression Device
932 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability
933 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for Industry; Availability.
934 Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations-Revised Benchmark Rebasing Methodology, Facilitating Transition to Performance-Based Risk, and Administrative Finality of Financial Calculations
935 Advisory Committee; Transmissible Spongiform Encephalopathies Advisory Committee; Termination
936 New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Changes of Sponsorship
937 New Animal Drugs; Withdrawal of Approval of a New Animal Drug Application
938 Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
939 State Health Insurance Assistance Program (SHIP)
940 Medicare and Medicaid Programs; Electronic Health Record Incentive Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017; Corrections and Correcting Amendment
941 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016; Corrections
942 Medical Devices; Ophthalmic Devices; Classification of the Diurnal Pattern Recorder System
943 Food Labeling: Revision of the Nutrition and Supplement Facts Labels
944 Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments
945 Mitigation Strategies To Protect Food Against Intentional Adulteration
946 Cardiovascular Devices; Reclassification of External Cardiac Compressor; Reclassification of Cardiopulmonary Resuscitation Aids
947 Medicare Program; Obtaining Final Medicare Secondary Payer Conditional Payment Amounts via Web Portal
948 Antimicrobial Animal Drug Sales and Distribution Reporting
949 Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Cigars and Pipe Tobacco
950 Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
951 Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability
952 Standard Preparations, Limits of Potency, and Dating Period Limitations for Biological Products
953 Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities
954 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Technical Amendment
955 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Correction
956 Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Technical Amendment
957 Medicare Program; Temporary Exception for Certain Severe Wound Discharges From Certain Long-Term Care Hospitals Required by the Consolidated Appropriations Act, 2016; Modification of Limitations on Redesignation by the Medicare Geographic Classification Review Board
958 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
959 Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers
960 Food Additives Permitted for Direct Addition to Food for Human Consumption; Folic Acid
961 Exempt Infant Formula Production: Current Good Manufacturing Practices, Quality Control Procedures, Conduct of Audits, and Records and Reports; Guidance for Industry; Availability
962 Medicaid Program; Deadline for Access Monitoring Review Plan Submissions
963 Sanitary Transportation of Human and Animal Food
964 Administrative Actions for Noncompliance; Lesser Administrative Actions
965 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
966 New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship
967 Medicaid and Children's Health Insurance Programs; Mental Health Parity and Addiction Equity Act of 2008; the Application of Mental Health Parity Requirements to Coverage Offered by Medicaid Managed Care Organizations, the Children's Health Insurance Program (CHIP), and Alternative Benefit Plans
968 Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical Amendment
969 Patient Engagement Advisory Committee
970 Use of Materials Derived From Cattle in Human Food and Cosmetics
971 Eligibility in the States, District of Columbia, the Northern Mariana Islands, and American Samoa
972 Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016; Corrections
973 Pharmaceutical Science and Clinical Pharmacology Advisory Committee
974 New Animal Drugs for Use in Animal Feeds; Removal of Obsolete and Redundant Regulations
975 Unique Device Identification System; Editorial Provisions; Technical Amendment
976 Eligibility in the States, District of Columbia, the Northern Mariana Islands, and American Samoa
977 Medicare and Medicaid Programs; Electronic Health Record Initiative Program-Stage 3 and Modifications to Meaningful Use in 2015 Through 2017; Corrections and Correcting Amendment
978 Medicare Program; Comprehensive Care for Joint Replacement Payment Model for Acute Care Hospitals Furnishing Lower Extremity Joint Replacement Services; Corrections and Correcting Amendments
979 Basic Health Program; Federal Funding Methodology for Program Years 2017 and 2018
980 The Food and Drug Administration Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation; Public Meeting
981 Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids; Small Entity Compliance Guide; Availability
982 Effective Date of Requirement for Premarket Approval for Total Metal-on-Metal Semi-Constrained Hip Joint Systems
983 Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972
984 Anesthesiology Devices; Reclassification of Membrane Lung for Long-Term Pulmonary Support; Redesignation as Extracorporeal Circuit and Accessories for Long-Term Respiratory/Cardiopulmonary Failure
985 Medical Devices; General and Plastic Surgery Devices; Classification of the Scalp Cooling System To Reduce the Likelihood of Chemotherapy-Induced Alopecia
986 Medicare Program; Reporting and Returning of Overpayments
987 State Health Insurance Assistance Program (SHIP)
988 Center for Food Safety and Applied Nutrition Library Address; Technical Amendments
989 Medicaid Program; Face-to-Face Requirements for Home Health Services; Policy Changes and Clarifications Related to Home Health
990 Medicaid Program; Covered Outpatient Drugs
991 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Correction
992 Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings
993 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food; Technical Amendment
994 Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Technical Amendment
995 Conditional Approval of a New Animal Drug No Longer in Effect; Masitinib
996 Medical Devices; Ear, Nose, and Throat Devices; Classification of the Tympanic Membrane Contact Hearing Aid
997 Medical Devices; Obstetrical and Gynecological Devices; Classification of the Intravaginal Culture System
998 Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
999 Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
1000 Indirect Food Additives: Paper and Paperboard Components
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agency_names
1 Health and Human Services Department; Food and Drug Administration
2 Health and Human Services Department; Food and Drug Administration
3 Treasury Department; Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
4 Health and Human Services Department; Centers for Medicare & Medicaid Services
5 Health and Human Services Department; Food and Drug Administration
6 Health and Human Services Department; Food and Drug Administration
7 Health and Human Services Department; Centers for Medicare & Medicaid Services
8 Health and Human Services Department; Food and Drug Administration
9 Health and Human Services Department; Centers for Medicare & Medicaid Services
10 Health and Human Services Department; Centers for Medicare & Medicaid Services
11 Health and Human Services Department; Centers for Medicare & Medicaid Services
12 Health and Human Services Department; Centers for Medicare & Medicaid Services
13 Health and Human Services Department; Centers for Medicare & Medicaid Services
14 Health and Human Services Department; Centers for Medicare & Medicaid Services
15 Health and Human Services Department; Centers for Medicare & Medicaid Services
16 Health and Human Services Department; Centers for Medicare & Medicaid Services
17 Health and Human Services Department; Centers for Medicare & Medicaid Services
18 Health and Human Services Department; Food and Drug Administration
19 Health and Human Services Department; Food and Drug Administration
20 Health and Human Services Department; Food and Drug Administration
21 Health and Human Services Department; Food and Drug Administration
22 Health and Human Services Department; Food and Drug Administration
23 Health and Human Services Department; Food and Drug Administration
24 Health and Human Services Department; Food and Drug Administration
25 Health and Human Services Department; Food and Drug Administration
26 Health and Human Services Department; Food and Drug Administration
27 Health and Human Services Department; Food and Drug Administration
28 Health and Human Services Department; Food and Drug Administration
29 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
30 Health and Human Services Department; Food and Drug Administration
31 Health and Human Services Department; Food and Drug Administration
32 Health and Human Services Department; Food and Drug Administration
33 Health and Human Services Department; Food and Drug Administration
34 Health and Human Services Department; Food and Drug Administration
35 Health and Human Services Department; Food and Drug Administration
36 Health and Human Services Department; Food and Drug Administration
37 Health and Human Services Department; Food and Drug Administration
38 Health and Human Services Department; Food and Drug Administration
39 Health and Human Services Department; Food and Drug Administration
40 Health and Human Services Department; Food and Drug Administration
41 Health and Human Services Department; Food and Drug Administration
42 Health and Human Services Department; Centers for Medicare & Medicaid Services
43 Health and Human Services Department; Food and Drug Administration
44 Health and Human Services Department; Food and Drug Administration
45 Health and Human Services Department; Food and Drug Administration
46 Health and Human Services Department; Food and Drug Administration
47 Health and Human Services Department; Food and Drug Administration
48 Health and Human Services Department; Centers for Medicare & Medicaid Services
49 Health and Human Services Department; Centers for Medicare & Medicaid Services
50 Health and Human Services Department; Centers for Medicare & Medicaid Services
51 Health and Human Services Department; Centers for Medicare & Medicaid Services
52 Health and Human Services Department; Centers for Medicare & Medicaid Services
53 Health and Human Services Department; Food and Drug Administration
54 Health and Human Services Department; Centers for Medicare & Medicaid Services
55 Health and Human Services Department; Food and Drug Administration
56 Health and Human Services Department; Food and Drug Administration
57 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
58 Health and Human Services Department; Centers for Medicare & Medicaid Services
59 Health and Human Services Department; Centers for Medicare & Medicaid Services
60 Health and Human Services Department; Centers for Medicare & Medicaid Services
61 Health and Human Services Department; Food and Drug Administration
62 Health and Human Services Department; Food and Drug Administration
63 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
64 Health and Human Services Department; Food and Drug Administration
65 Health and Human Services Department; Food and Drug Administration
66 Health and Human Services Department; Food and Drug Administration
67 Health and Human Services Department; Food and Drug Administration
68 Health and Human Services Department; Food and Drug Administration
69 Health and Human Services Department; Food and Drug Administration
70 Health and Human Services Department; Food and Drug Administration
71 Health and Human Services Department; Centers for Medicare & Medicaid Services
72 Health and Human Services Department; Centers for Medicare & Medicaid Services
73 Health and Human Services Department; Centers for Medicare & Medicaid Services
74 Health and Human Services Department; Centers for Medicare & Medicaid Services
75 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
76 Health and Human Services Department; Food and Drug Administration
77 Health and Human Services Department; Food and Drug Administration
78 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
79 Health and Human Services Department; Food and Drug Administration
80 Health and Human Services Department; Food and Drug Administration
81 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
82 Treasury Department; Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
83 Health and Human Services Department; Centers for Medicare & Medicaid Services
84 Health and Human Services Department; Centers for Medicare & Medicaid Services
85 Health and Human Services Department; Food and Drug Administration
86 Health and Human Services Department; Food and Drug Administration
87 Health and Human Services Department; Food and Drug Administration
88 Health and Human Services Department; Centers for Medicare & Medicaid Services
89 Health and Human Services Department; Food and Drug Administration
90 Health and Human Services Department; Centers for Medicare & Medicaid Services
91 Health and Human Services Department; Food and Drug Administration
92 Health and Human Services Department; Food and Drug Administration
93 Health and Human Services Department; Centers for Medicare & Medicaid Services
94 Health and Human Services Department; Food and Drug Administration
95 Health and Human Services Department; Food and Drug Administration
96 Health and Human Services Department; Centers for Medicare & Medicaid Services
97 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
98 Health and Human Services Department; Food and Drug Administration
99 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
100 Health and Human Services Department; Food and Drug Administration
101 Health and Human Services Department; Centers for Medicare & Medicaid Services
102 Health and Human Services Department; Centers for Medicare & Medicaid Services
103 Health and Human Services Department; Food and Drug Administration
104 Health and Human Services Department; Food and Drug Administration
105 Health and Human Services Department; Centers for Medicare & Medicaid Services
106 Health and Human Services Department; Food and Drug Administration
107 Health and Human Services Department; Food and Drug Administration
108 Health and Human Services Department; Food and Drug Administration
109 Health and Human Services Department; Food and Drug Administration
110 Health and Human Services Department; Food and Drug Administration
111 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
112 Health and Human Services Department; Food and Drug Administration
113 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
114 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
115 Health and Human Services Department; Food and Drug Administration
116 Health and Human Services Department; Centers for Medicare & Medicaid Services
117 Health and Human Services Department; Centers for Medicare & Medicaid Services
118 Health and Human Services Department; Centers for Medicare & Medicaid Services
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259 Health and Human Services Department; Food and Drug Administration; Public Health Service; Centers for Medicare & Medicaid Services; Office of the Inspector General; Office of the Secretary; Children and Families Administration
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347 Health and Human Services Department; Centers for Medicare & Medicaid Services
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349 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
350 Health and Human Services Department; Office of the Secretary; Centers for Medicare & Medicaid Services; Office of the Inspector General; Office of the Secretary; Children and Families Administration
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352 Health and Human Services Department; Centers for Medicare & Medicaid Services
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382 Health and Human Services Department; Centers for Medicare & Medicaid Services
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392 Health and Human Services Department; Food and Drug Administration
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396 Health and Human Services Department; Food and Drug Administration; Public Health Service; Centers for Medicare & Medicaid Services; Office of the Inspector General; Office of the Secretary; Children and Families Administration
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399 Health and Human Services Department; Centers for Medicare & Medicaid Services
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406 Health and Human Services Department; Centers for Medicare & Medicaid Services
407 Health and Human Services Department; Centers for Medicare & Medicaid Services
408 Health and Human Services Department; Food and Drug Administration; Public Health Service; Centers for Medicare & Medicaid Services; Office of the Inspector General; Office of the Secretary; Children and Families Administration
409 Health and Human Services Department; Centers for Medicare & Medicaid Services
410 Health and Human Services Department; Food and Drug Administration
411 Health and Human Services Department; Centers for Medicare & Medicaid Services
412 Health and Human Services Department; Food and Drug Administration
413 Health and Human Services Department; Centers for Medicare & Medicaid Services
414 Health and Human Services Department; Centers for Medicare & Medicaid Services
415 Health and Human Services Department; Centers for Medicare & Medicaid Services
416 Health and Human Services Department; Centers for Medicare & Medicaid Services
417 Health and Human Services Department; Food and Drug Administration
418 Health and Human Services Department; Office of the Secretary; Food and Drug Administration; Centers for Medicare & Medicaid Services; Office of Inspector General; Children and Families Administration
419 Health and Human Services Department; Centers for Medicare & Medicaid Services
420 Health and Human Services Department; Centers for Medicare & Medicaid Services
421 Health and Human Services Department; Centers for Medicare & Medicaid Services
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423 Health and Human Services Department; Centers for Medicare & Medicaid Services
424 Health and Human Services Department; Centers for Medicare & Medicaid Services
425 Health and Human Services Department; Centers for Medicare & Medicaid Services
426 Health and Human Services Department; Office of the Secretary; Food and Drug Administration; Centers for Medicare & Medicaid Services; Office of Inspector General; Children and Families Administration
427 Health and Human Services Department; Centers for Medicare & Medicaid Services
428 Health and Human Services Department; Centers for Medicare & Medicaid Services
429 Treasury Department; Internal Revenue Service; Office of the Secretary; Labor Department; Employee Benefits Security Administration; Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
430 Health and Human Services Department; Centers for Medicare & Medicaid Services
431 Health and Human Services Department; Food and Drug Administration
432 Health and Human Services Department; Centers for Medicare & Medicaid Services
433 Health and Human Services Department; Centers for Medicare & Medicaid Services
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435 Health and Human Services Department; Centers for Medicare & Medicaid Services
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437 Health and Human Services Department; Centers for Medicare & Medicaid Services
438 Health and Human Services Department; Centers for Medicare & Medicaid Services
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440 Health and Human Services Department; Centers for Medicare & Medicaid Services
441 Health and Human Services Department; Centers for Medicare & Medicaid Services
442 Health and Human Services Department; Centers for Medicare & Medicaid Services
443 Health and Human Services Department; Centers for Medicare & Medicaid Services
444 Health and Human Services Department; Food and Drug Administration
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446 Health and Human Services Department; Food and Drug Administration
447 Health and Human Services Department; Food and Drug Administration
448 Health and Human Services Department; Centers for Medicare & Medicaid Services
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450 Health and Human Services Department; Food and Drug Administration
451 Health and Human Services Department; Centers for Medicare & Medicaid Services
452 Health and Human Services Department; Centers for Medicare & Medicaid Services
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455 Health and Human Services Department; Food and Drug Administration
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457 Health and Human Services Department; Food and Drug Administration
458 Health and Human Services Department; Food and Drug Administration
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461 Health and Human Services Department; Food and Drug Administration
462 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
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465 Health and Human Services Department; Centers for Medicare & Medicaid Services
466 Health and Human Services Department; Food and Drug Administration
467 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
468 Health and Human Services Department; Food and Drug Administration
469 Health and Human Services Department; Centers for Medicare & Medicaid Services; Office of the Secretary
470 Health and Human Services Department; Food and Drug Administration
471 Health and Human Services Department; Centers for Medicare & Medicaid Services
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484 Health and Human Services Department; Centers for Medicare & Medicaid Services
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499 Health and Human Services Department; Centers for Medicare & Medicaid Services
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501 Health and Human Services Department; Food and Drug Administration
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507 Health and Human Services Department; Centers for Medicare & Medicaid Services
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510 Health and Human Services Department; Food and Drug Administration
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515 Health and Human Services Department; Centers for Medicare & Medicaid Services
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517 Health and Human Services Department; Centers for Medicare & Medicaid Services
518 Health and Human Services Department; Centers for Medicare & Medicaid Services
519 Health and Human Services Department; Centers for Medicare & Medicaid Services
520 Health and Human Services Department; Centers for Medicare & Medicaid Services
521 Health and Human Services Department; Centers for Medicare & Medicaid Services
522 Health and Human Services Department; Food and Drug Administration
523 Health and Human Services Department; Food and Drug Administration
524 Health and Human Services Department; Centers for Medicare & Medicaid Services
525 Health and Human Services Department; Centers for Medicare & Medicaid Services
526 Health and Human Services Department; Centers for Medicare & Medicaid Services
527 Health and Human Services Department; Centers for Medicare & Medicaid Services
528 Health and Human Services Department; Food and Drug Administration
529 Health and Human Services Department; Centers for Medicare & Medicaid Services
530 Health and Human Services Department; Food and Drug Administration
531 Health and Human Services Department; Food and Drug Administration
532 Health and Human Services Department; Food and Drug Administration
533 Health and Human Services Department; Food and Drug Administration
534 Health and Human Services Department; Food and Drug Administration
535 Health and Human Services Department; Food and Drug Administration
536 Health and Human Services Department; Centers for Medicare & Medicaid Services
537 Health and Human Services Department; Centers for Medicare & Medicaid Services
538 Health and Human Services Department; Centers for Medicare & Medicaid Services
539 Health and Human Services Department; Food and Drug Administration
540 Health and Human Services Department; Centers for Medicare & Medicaid Services
541 Health and Human Services Department; Food and Drug Administration
542 Health and Human Services Department; Centers for Medicare & Medicaid Services
543 Health and Human Services Department; Centers for Medicare & Medicaid Services
544 Health and Human Services Department; Centers for Medicare & Medicaid Services
545 Health and Human Services Department; Centers for Medicare & Medicaid Services
546 Health and Human Services Department; Food and Drug Administration
547 Health and Human Services Department; Centers for Medicare & Medicaid Services
548 Health and Human Services Department; Centers for Medicare & Medicaid Services
549 Health and Human Services Department; Food and Drug Administration
550 Health and Human Services Department; Centers for Medicare & Medicaid Services
551 Health and Human Services Department; Food and Drug Administration
552 Health and Human Services Department; Food and Drug Administration
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560 Health and Human Services Department; Food and Drug Administration
561 Health and Human Services Department; Centers for Medicare & Medicaid Services
562 Health and Human Services Department; Food and Drug Administration
563 Health and Human Services Department; Centers for Medicare & Medicaid Services
564 Health and Human Services Department; Food and Drug Administration
565 Health and Human Services Department; Centers for Medicare & Medicaid Services
566 Health and Human Services Department; Food and Drug Administration
567 Health and Human Services Department; Food and Drug Administration
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569 Health and Human Services Department; Food and Drug Administration
570 Health and Human Services Department; Food and Drug Administration
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573 Health and Human Services Department; Food and Drug Administration
574 Health and Human Services Department; Food and Drug Administration
575 Health and Human Services Department; Food and Drug Administration
576 Health and Human Services Department; Centers for Medicare & Medicaid Services
577 Health and Human Services Department; Centers for Medicare & Medicaid Services
578 Health and Human Services Department; Centers for Medicare & Medicaid Services
579 Health and Human Services Department; Centers for Medicare & Medicaid Services
580 Health and Human Services Department; Food and Drug Administration
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587 Health and Human Services Department; Food and Drug Administration
588 Health and Human Services Department; Centers for Medicare & Medicaid Services
589 Health and Human Services Department; Centers for Medicare & Medicaid Services
590 Health and Human Services Department; Centers for Medicare & Medicaid Services
591 Health and Human Services Department; Centers for Medicare & Medicaid Services
592 Health and Human Services Department; Food and Drug Administration
593 Health and Human Services Department; Centers for Medicare & Medicaid Services
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595 Health and Human Services Department; Centers for Medicare & Medicaid Services
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609 Health and Human Services Department; Food and Drug Administration
610 Health and Human Services Department; Food and Drug Administration
611 Health and Human Services Department; Food and Drug Administration
612 Health and Human Services Department; Centers for Medicare & Medicaid Services
613 Health and Human Services Department; Centers for Medicare & Medicaid Services
614 Health and Human Services Department; Food and Drug Administration
615 Health and Human Services Department; Food and Drug Administration
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617 Health and Human Services Department; Food and Drug Administration
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623 Health and Human Services Department; Centers for Medicare & Medicaid Services
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625 Health and Human Services Department; Centers for Medicare & Medicaid Services
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627 Health and Human Services Department; Centers for Medicare & Medicaid Services
628 Health and Human Services Department; Centers for Medicare & Medicaid Services
629 Health and Human Services Department; Centers for Medicare & Medicaid Services
630 Health and Human Services Department; Centers for Medicare & Medicaid Services
631 Health and Human Services Department; Centers for Medicare & Medicaid Services
632 Health and Human Services Department; Centers for Medicare & Medicaid Services
633 Health and Human Services Department; Food and Drug Administration
634 Health and Human Services Department; Food and Drug Administration
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636 Health and Human Services Department; Food and Drug Administration
637 Health and Human Services Department; Centers for Medicare & Medicaid Services
638 Health and Human Services Department; Food and Drug Administration
639 Health and Human Services Department; Food and Drug Administration
640 Health and Human Services Department; Food and Drug Administration
641 Health and Human Services Department; Food and Drug Administration
642 Health and Human Services Department; Centers for Medicare & Medicaid Services
643 Health and Human Services Department; Food and Drug Administration
644 Health and Human Services Department; Food and Drug Administration
645 Health and Human Services Department; Centers for Medicare & Medicaid Services
646 Health and Human Services Department; Centers for Medicare & Medicaid Services
647 Health and Human Services Department; Food and Drug Administration
648 Health and Human Services Department; Food and Drug Administration
649 Health and Human Services Department; Food and Drug Administration
650 Health and Human Services Department; Food and Drug Administration
651 Health and Human Services Department; Centers for Medicare & Medicaid Services
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656 Health and Human Services Department; Food and Drug Administration
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658 Health and Human Services Department; Centers for Medicare & Medicaid Services
659 Health and Human Services Department; Centers for Medicare & Medicaid Services
660 Health and Human Services Department; Centers for Medicare & Medicaid Services
661 Health and Human Services Department; Food and Drug Administration
662 Health and Human Services Department; Food and Drug Administration
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665 Health and Human Services Department; Centers for Medicare & Medicaid Services
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670 Health and Human Services Department; Food and Drug Administration
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677 Health and Human Services Department; Food and Drug Administration
678 Health and Human Services Department; Food and Drug Administration
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680 Health and Human Services Department; Food and Drug Administration
681 Health and Human Services Department; Centers for Medicare & Medicaid Services
682 Health and Human Services Department; Food and Drug Administration
683 Health and Human Services Department; Centers for Medicare & Medicaid Services
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685 Health and Human Services Department; Food and Drug Administration
686 Health and Human Services Department; Food and Drug Administration
687 Health and Human Services Department; Food and Drug Administration
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690 Health and Human Services Department; Food and Drug Administration
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abstract
1 The Food and Drug Administration (FDA or we) is responding to the objection that we received from the Environmental Defense Fund, Breast Cancer Prevention Partners, Environmental Protection Network, Environmental Working Group, and Healthy Babies Bright Futures on the final rule that amended the food additive regulations to no longer provide for the use of 25 plasticizers that the petition identified as ortho-phthalates because these food additive uses have been permanently abandoned. After reviewing the objection, FDA has concluded that the objection does not provide a basis for modifying FDA's final rule amending the food additive regulations.
2 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during April, May, and June 2024. The animal drug regulations are also being amended to improve their accuracy and readability.
3 This document corrects technical and typographical errors in the final rule that appeared in the April 15, 2024 issue of the Federal Register entitled, "Patient Protection and Affordable Care Act, HHS Notice of Benefit and Payment Parameters for 2025; Updating Section 1332 Waiver Public Notice Procedures; Medicaid; Consumer Operated and Oriented Plan (CO-OP) Program; and Basic Health Program." The effective date of the final rule was June 4, 2024.
4 This document corrects technical errors in the final rule that appeared in the February 8, 2024 Federal Register titled "Medicare and Medicaid Programs; Patient Protection and Affordable Care Act; Advancing Interoperability and Improving Prior Authorization Processes for Medicare Advantage Organizations, Medicaid Managed Care Plans, State Medicaid Agencies, Children's Health Insurance Program (CHIP) Agencies and CHIP Managed Care Entities, Issuers of Qualified Health Plans on the Federally-Facilitated Exchanges, Merit-Based Incentive Payment System (MIPS) Eligible Clinicians, and Eligible Hospitals and Critical Access Hospitals in the Medicare Promoting Interoperability Program".
5 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #293 entitled "FDA Enforcement Policy for AAFCO-Defined Animal Feed Ingredients." This communicates FDA's enforcement policy regarding ingredients listed in chapter six of the 2024 Association of American Feed Control Officials (AAFCO) Official Publication after the Agency's memorandum of understanding with AAFCO expired on October 1, 2024.
6 The Food and Drug Administration (FDA, Agency, or we) is correcting a final rule entitled "Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments" that appeared in the Federal Register of September 20, 2024. The final rule inadvertently omitted the effective date for a provision in the regulatory text. This document corrects the error in the DATES portion.
7 This final rule implements an order from the Federal district court for the District of Connecticut in Alexander v. Azar that requires HHS to establish appeals processes for certain Medicare beneficiaries who are initially admitted as hospital inpatients but are subsequently reclassified as outpatients receiving observation services during their hospital stay and meet other eligibility criteria.
8 The Food and Drug Administration (FDA or Agency) is correcting a final rule that appeared in the Federal Register on February 2, 2024. In that final rule, FDA amended the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the device CGMP. FDA is correcting an editorial error that inadvertently omitted a definition in the codified of the final rule. This action is editorial in nature and is intended to ensure the accuracy and clarity of the Agency's regulations.
9 This interim final action with comment period (IFC) implements revised Medicare wage index values for FY 2025, establishes a transitional payment exception for low wage hospitals significantly impacted by those revisions, and makes conforming changes to the hospital Inpatient Prospective Payment System (IPPS) payment rates for FY 2025. These changes reflect the removal of the low wage index hospital policy following the appellate court decision in Bridgeport Hosp. v. Becerra. This rule also makes conforming changes to IPPS rates and factors used to determine certain payments under the Long-Term Care Hospital Prospective Payment System (LTCH PPS).
10 This document corrects technical errors in the final action that appeared in the August 7, 2024 Federal Register titled "Medicare Program; FY 2025 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update".
11 This document corrects technical and typographical errors in the final rule that appeared in the August 28, 2024 Federal Register titled "Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes" (referred to hereafter as the "FY 2025 IPPS/LTCH PPS final rule").
12 This document corrects technical and typographical errors in the final rule that appeared in the August 6, 2024 Federal Register entitled "Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2025 and Updates to the IRF Quality Reporting Program" (referred to hereafter as the "FY 2025 IRF final rule"). The effective date of the FY 2025 IRF final rule is October 1, 2024.
13 This document corrects technical errors in the final rule that appeared in the August 6, 2024 Federal Register, titled "Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF); Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2025" (referred to hereafter as the "FY 2025 SNF final rule"). The effective date of the FY 2025 SNF final rule is October 1, 2024.
14 This document corrects technical and typographical errors in the final rule that appeared in the August 6, 2024 Federal Register titled "Medicare Program; FY 2025 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, and Hospice Quality Reporting Program Requirements".
15 This document corrects technical and typographical errors in the final rule that appeared in the April 23, 2024 Federal Register titled "Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-- Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All- Inclusive Care for the Elderly (PACE)." The effective date of the final rule was June 3, 2024.
16 This final rule addresses policies for assessing performance year (PY) 2023 financial performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs); establishing benchmarks for ACOs starting agreement periods in 2024, 2025, and 2026; and calculating factors used in the application cycle for ACOs applying to enter a new agreement period beginning on January 1, 2025, and the change request cycle for ACOs continuing their participation in the program for PY 2025, as a result of significant, anomalous, and highly suspect billing activity for selected intermittent urinary catheters on Medicare Durable Medical Equipment, Prosthetics, Orthotics & Supplies (DMEPOS) claims. Under the Shared Savings Program, providers of services and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Medicare Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs participating in two-sided models may also share in losses. In this final rule, we respond to public comments we received on the proposal to mitigate the impact of significant, anomalous, and highly suspect billing activity on Medicare Shared Savings Program financial calculations in calendar year (CY) 2023.
17 This final rule implements policies in the Medicaid Drug Rebate Program (MDRP) related to the new legislative requirements in the Medicaid Services Investment and Accountability Act of 2019 (MSIAA), which address drug misclassification, as well as drug pricing and product data misreporting by manufacturers. Additionally, we are finalizing several other proposed program integrity and program administration provisions or modifications in this final rule, including revising and finalizing key definitions used in the MDRP. This rule also finalizes a provision not directly related to MDRP that makes revisions to the third-party liability regulation due to amendments made by the Bipartisan Budget Act (BBA) of 2018. We also are finalizing our proposal to rescind revisions made by the December 31, 2020 final rule "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements" ("the 2020 final rule") to the Determination of Best Price and Determination of Average Manufacturer Price (AMP) sections.
18 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide." We are updating the small entity compliance guide (SECG) to help small entities comply with revised requirements related to agricultural water in the "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" regulation.
19 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification.
20 The Food and Drug Administration (FDA, Agency, or we) is issuing a direct final rule amending the Scope section of our regulation that provides for a regulatory hearing before the Agency in order to clarify when such hearings are available. We are revising the list of statutory provisions enumerated in the Scope section of the regulation by adding one statutory reference and removing a different statutory reference. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.
21 The Food and Drug Administration (FDA, Agency, or we) is classifying the quantitative viral nucleic acid test for transplant patient management into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the quantitative viral nucleic acid test for transplant patient management's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
22 The Food and Drug Administration (FDA, Agency, or we) is classifying the clozapine test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the clozapine test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
23 The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect or measure nucleic acid from viruses associated with head and neck cancers into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect or measure nucleic acid from viruses associated with head and neck cancers' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
24 The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric continuous renal replacement therapy system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pediatric continuous renal replacement therapy system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
25 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements." This guidance describes FDA's enforcement policy for the final rule, "Tobacco Products; Required Warnings for Cigarette Packages and Advertisements," which established new required cigarette health warnings for cigarette packages and advertisements. The guidance is intended to assist entities required to comply with the rule.
26 The Food and Drug Administration (FDA, Agency, or we) is classifying the whole exome sequencing constituent device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole exome sequencing constituent device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
27 The Food and Drug Administration (FDA, Agency, or we) is classifying the blood collection device for cell-free nucleic acids into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the blood collection device for cell-free nucleic acids' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
28 The Food and Drug Administration (FDA or we) is classifying the endoscopic pancreatic debridement device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic pancreatic debridement device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
29 This document corrects typographical and technical errors in the final rule that appeared in the June 17, 2024, Federal Register, titled "Medicare Program; Medicare Prescription Drug Benefit Program; Health Information Technology Standards and Implementation Specifications." The effective date of the final rule was July 17, 2024.
30 The Food and Drug Administration (FDA or we) is classifying the hemodialyzer with expanded solute removal profile into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hemodialyzer with expanded solute removal profile's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
31 The Food and Drug Administration (FDA) is amending the food additive regulations to update the organism Pichia pastoris which has been renamed as Komagataella pastoris. Additionally, the food additive regulation is being updated to include language to clarify that the yeast is non-viable in the market formulation. This action is being taken to improve the accuracy of the regulations.
32 The Food and Drug Administration (FDA or we) is classifying the heparin and direct oral factor Xa inhibitor drug test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the heparin and direct oral factor Xa inhibitor drug test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
33 The Food and Drug Administration (FDA, Agency, or we) is classifying the adjunctive open loop fluid therapy recommender into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the adjunctive open loop fluid therapy recommender's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
34 The Food and Drug Administration (FDA or we) is classifying the radiofrequency toothbrush into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiofrequency toothbrush's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
35 The Food and Drug Administration (FDA, Agency, or we) is classifying the hydrophilic re-coating solution into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hydrophilic re-coating solution's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
36 The Food and Drug Administration (FDA, Agency, or we) is classifying the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the neuromuscular tongue muscle stimulator for the reduction of snoring and obstructive sleep apnea's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
37 The Food and Drug Administration (FDA or we) is classifying the digital therapy device for Attention Deficit Hyperactivity Disorder into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the digital therapy device for Attention Deficit Hyperactivity Disorder's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
38 The Food and Drug Administration (FDA, Agency, or we) is classifying the intervertebral body graft containment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intervertebral body graft containment device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
39 The Food and Drug Administration (FDA or we) is classifying the external compression device for internal jugular vein compression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external compression device for internal jugular vein compression's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
40 The Food and Drug Administration is issuing a final rule to make conforming changes as required by the Further Consolidated Appropriations Act, 2020 (Appropriations Act), which established a new Federal minimum age of sale for tobacco products. These conforming changes include increasing the minimum age of sale for cigarettes, smokeless tobacco, and covered tobacco products from 18 to 21 years of age; increasing the minimum age for age verification by means of photographic identification for cigarettes, smokeless tobacco, and covered tobacco products from under the age of 27 to under the age of 30; increasing the minimum age of individuals who may be present or permitted to enter facilities that maintain vending machines to sell cigarettes, smokeless tobacco, or covered tobacco products from 18 to 21 years of age; and increasing the minimum age of individuals who may be present or permitted to enter facilities that maintain self-service displays that sell cigarettes or smokeless tobacco from 18 to 21 years of age.
41 The Food and Drug Administration (FDA, Agency, or we) is announcing a minor, technical modification to an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the "Voluntary Malfunction Summary Reporting Program."
42 This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; makes changes relating to Medicare graduate medical education (GME) for teaching hospitals; updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); and makes other policy- related changes.
43 The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide." The Mammography Quality Standards Act of 1992 (MQSA) final rule amended FDA's regulations to address, among other things, standards for accreditation bodies, certifying agencies, mammography equipment, quality assurance testing, and clinical image quality, as well as to require certain breast density information be provided by mammography facilities to patients and their healthcare providers. The small entity compliance guide (SECG) is intended to help small entities comply with the MQSA final rule.
44 The Food and Drug Administration (FDA) is amending the food additive regulations to update the production organism Lactobacillus bulgaricus that has been scientifically reclassified to Lactobacillus delbrueckii. This action is being taken to improve the accuracy and clarity of the regulations.
45 The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
46 The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect and identify selected microbial agents that cause acute febrile illness into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify selected microbial agents that cause acute febrile illness's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
47 The Food and Drug Administration (FDA, Agency, or we) is classifying the intravenous catheter force-activated separation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intravenous catheter force-activated separation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
48 This final action updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This final action also revises the patient-level adjustment factors, the Emergency Department adjustment, and the payment amount for electroconvulsive therapy. These changes will be effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2024 through September 30, 2025 (FY 2025). In addition, this final action finalizes the adoption of a new quality measure. It does not finalize modifications to the reporting requirements under the IPF Quality Reporting Program beginning with the FY 2027 payment determination. Furthermore, this final action summarizes comments received through Requests for Information regarding potential future revisions to the IPF PPS facility-level adjustments and regarding the development of a standardized IPF Patient Assessment Instrument.
49 This document corrects technical and typographical errors in the final rule that appeared in the April 23, 2024 Federal Register titled "Medicare Program; Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Program for Contract Year 2024-- Remaining Provisions and Contract Year 2025 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All- Inclusive Care for the Elderly (PACE)." The effective date of the final rule was June 3, 2024.
50 This final rule finalizes changes and updates to the policies and payment rates used under the Skilled Nursing Facility (SNF) Prospective Payment System (PPS) for fiscal year (FY) 2025. First, we are rebasing and revising the SNF market basket to reflect a 2022 base year. Next, we update the wage index used under the SNF PPS to reflect data collected during the most recent decennial census. Additionally, we finalize several technical revisions to the code mappings used to classify patients under the Patient Driven Payment Model (PDPM) to improve payment and coding accuracy. This final rule also updates the requirements for the SNF Quality Reporting Program and the SNF Value- Based Purchasing Program. Finally, we also are revising CMS' enforcement authority for imposing civil money penalties (CMPs) and including revisions to strengthen nursing home enforcement regulations.
51 This final rule updates the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2025. This rule also adopts the most recent Office of Management and Budget statistical area delineations, which will impact the hospice wage index. This rule clarifies current policy related to the "election statement" and the "notice of election", as well as adds clarifying language regarding hospice certification and includes a technical regulation text change to the Conditions of Participation (CoPs). This rule finalizes changes to the Hospice Quality Reporting Program. Finally, this rule summarizes comments received regarding potential implementation of a separate payment mechanism to account for high intensity palliative care services.
52 This final action updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2025. As required by statute, this final action includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2025. We are updating the Office of Management and Budget (OMB) market area delineations for the IRF prospective payment system (PPS) wage index and applying a 3-year phase-out of the rural adjustment. This rule also includes updates for the IRF Quality Reporting Program (QRP).
53 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Guidance for Industry." The guidance document addresses certain regulatory requirements for determining donor eligibility that apply to blood establishments that collect blood and blood components for transfusion or for further manufacturing use, including Source Plasma. In a final rule dated May 22, 2015, FDA amended the regulations applicable to blood establishments for determining donor eligibility and testing blood and blood components. The revised requirements were implemented in order to assure the safety of the blood supply and to protect donor health. This guidance finalizes the draft guidance entitled "Blood Pressure and Pulse Donor Eligibility Requirements: Compliance Policy; Draft Guidance for Industry" issued on May 24, 2022.
54 This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and have earned an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current information needed to disburse the payment. This advisory provides information to QPs on how to update their Medicare billing information so that CMS can disburse APM Incentive Payments.
55 The Food and Drug Administration (FDA or Agency) is announcing the termination of the Allergenic Products Advisory Committee, Center for Biologics Evaluation and Research. This document announces the reasons for termination and removes the Allergenic Products Advisory Committee from the Agency's list of standing advisory committees.
56 The Food and Drug Administration (FDA or we) is amending our regulations to revoke the authorization for the use of brominated vegetable oil (BVO) in food. This action is being taken because there is no longer a reasonable certainty of no harm from the continued use of BVO in food. Specifically, the final rule revokes the authorization for the use of BVO as a food ingredient intended to stabilize flavoring oils in fruit-flavored beverages. There are no authorizations for other uses of BVO in food.
57 This final rule implements the provision of the 21st Century Cures Act specifying that a health care provider determined by the HHS Inspector General to have committed information blocking shall be referred to the appropriate agency to be subject to appropriate disincentives set forth through notice and comment rulemaking. This rulemaking establishes, for certain health care providers, a set of appropriate disincentives using authorities under applicable Federal law.
58 This document corrects technical and typographical errors in the final rule that appeared in the May 10, 2024 Federal Register, entitled "Medicaid Program; Ensuring Access to Medicaid Services (referred to hereafter as the "Access final rule"). The effective date of the Access final rule is July 9, 2024.
59 This document corrects typographical errors in the final rule that appeared in the May 10, 2024 Federal Register, entitled "Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (referred to hereafter as the "Managed Care final rule"). The effective date of the Managed Care final rule is July 9, 2024.
60 This document corrects typographical and technical errors in the final rule that appeared in the May 10, 2024 Federal Register, entitled "Medicare and Medicaid Programs; Minimum Staffing Standards for Long-Term Care Facilities and Medicaid Institutional Payment Transparency Reporting (referred to hereafter as the "Minimum Staffing final rule"). The effective date of the Minimum Staffing final rule is June 21, 2024.
61 The Food and Drug Administration (FDA or the Agency) is amending the regulations for medicated feed mill applications and for veterinary feed directive drugs to update addresses and simplify notification procedures. These technical amendments are being made to improve the accuracy of the Agency's regulations and are non- substantive.
62 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule revising the requirements concerning current good manufacturing practice (CGMP), postmarketing safety reporting, and labeling that apply to certain medical gases. This final rule also establishes regulations regarding certification of designated medical gases. This final rule satisfies the medical gas rulemaking requirements of the Consolidated Appropriations Act, 2017.
63 This final rule will revise the Medicare Prescription Drug Benefit (Part D) and ONC regulations to implement changes related to required standards for electronic prescribing and adoption of health information technology (IT) standards for HHS use.
64 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of ethyl cellulose as a matrix scaffolding for tracers, and the ethyl cellulose shall not exceed 80 percent of the tracer. This action is in response to a food additive petition filed by Micro-Tracers, Inc.
65 The Food and Drug Administration (FDA or we) has determined that there is sufficient laboratory capacity in the Laboratory Accreditation for Analyses of Foods (LAAF) program for the import- related food testing covered by the LAAF regulation for mycotoxins. As sufficient capacity is reached for additional analytes covered under the import-related food testing provisions of the LAAF regulation, those specific analytes and compliance dates will be posted on the LAAF Dashboard. Owners and consignees of imported food subject to the LAAF regulation must use a LAAF-accredited laboratory to conduct covered import-related food testing starting on the applicable compliance date, which is 6 months from the date a specific analyte is listed on a public registry, based on FDA's determination that sufficient laboratory capacity has been achieved for such analyte. FDA has not yet made a capacity determination for the other food testing circumstances covered by the LAAF regulation.
66 The Food and Drug Administration (FDA, Agency, or we) is issuing a regulation to implement our authority to destroy a device valued at $2,500 or less (or such higher amount as the Secretary of the Treasury may set by regulation) that has been refused admission into the United States by providing to the owner or consignee notice and an opportunity to appear and introduce testimony prior to the destruction. We are finalizing the change to our internal procedures for administrative destruction of drugs and devices. The notice of proposed rule making (NPRM) published in the Federal Register (October 7, 2022).
67 The Food and Drug Administration (FDA or Agency) is announcing the termination of the Science Advisory Board to the National Center for Toxicological Research (NCTR). This document announces the reasons for termination and removes the Science Advisory Board to the NCTR from the Agency's list of standing advisory committees.
68 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA is also establishing special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on valid scientific evidence. For this class II device, instead of a premarket approval application, manufacturers may submit a premarket notification, i.e., a 510(k) submission, and obtain FDA clearance of the device before marketing it.
69 The Food and Drug Administration (FDA, the Agency, or we) is amending the animal drug regulations for labeling of new animal drugs included on FDA's Index of Legally Marketed Unapproved New Animal Drugs for Minor Species (indexed products) to reflect the 2018 statutory changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This amendment is intended to ensure accuracy and clarity in the Agency's regulations. This amendment is nonsubstantive.
70 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2024. The animal drug regulations are also being amended to improve their accuracy and readability.
71 This document announces the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List. It also announces updates to the HCPCS codes on the Required Face-to-Face and Written Order Prior to Delivery List and the Required Prior Authorization List.
72 This final rule establishes minimum staffing standards for long-term care facilities, as part of the Biden-Harris Administration's nursing home reform initiative to ensure safe and quality care in long- term care facilities. In addition, this rule requires States to report the percent of Medicaid payments for certain Medicaid-covered institutional services that are spent on compensation for direct care workers and support staff.
73 This final rule will advance CMS's efforts to improve access to care, quality and health outcomes, and better address health equity issues for Medicaid and Children's Health Insurance Program (CHIP) managed care enrollees. The final rule addresses standards for timely access to care and States' monitoring and enforcement efforts, reduces State burdens for implementing some State directed payments (SDPs) and certain quality reporting requirements, adds new standards that will apply when States use in lieu of services and settings (ILOSs) to promote effective utilization and that specify the scope and nature of ILOSs, specifies medical loss ratio (MLR) requirements, and establishes a quality rating system for Medicaid and CHIP managed care plans.
74 This final rule takes a comprehensive approach to improving access to care, quality and health outcomes, and better addressing health equity issues in the Medicaid program across fee-for-service (FFS), managed care delivery systems, and in home and community-based services (HCBS) programs. These improvements increase transparency and accountability, standardize data and monitoring, and create opportunities for States to promote active beneficiary engagement in their Medicaid programs, with the goal of improving access to care.
75 This final rule makes several clarifications and updates the definitions currently used to determine whether a consumer is eligible to enroll in a Qualified Health Plan (QHP) through an Exchange; a Basic Health Program (BHP), in States that elect to operate a BHP; and for Medicaid and Children's Health Insurance Programs (CHIPs). Specifically, Deferred Action for Childhood Arrivals (DACA) recipients and certain other noncitizens will be included in the definitions of "lawfully present" that are used to determine eligibility to enroll in a QHP through an Exchange, for Advance Payments of the Premium Tax Credit (APTC) and Cost-Sharing Reductions (CSRs), or for a BHP.
76 The Food and Drug Administration is issuing a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. In conjunction with this amendment, the Food and Drug Administration is phasing out its general enforcement discretion approach for laboratory developed tests (LDTs) so that IVDs manufactured by a laboratory will generally fall under the same enforcement approach as other IVDs. This phaseout policy includes enforcement discretion policies for specific categories of IVDs manufactured by a laboratory, including currently marketed IVDs offered as LDTs and LDTs for unmet needs. This phaseout policy is intended to better protect the public health by helping to assure the safety and effectiveness of IVDs offered as LDTs, while also accounting for other important public health considerations such as patient access and reliance.
77 The Food and Drug Administration is issuing a final rule to amend the agricultural water provisions of the produce safety regulation. This rule replaces the microbial criteria and testing requirements for pre-harvest agricultural water for covered produce (other than sprouts) with a regulatory approach that incorporates recent science and Food and Drug Administration outbreak investigation findings to achieve improved public health protections as compared to the earlier requirements. The rule requires systems-based assessments, with required testing in certain circumstances, that focus on key risk factors for contamination by pre-harvest agricultural water and will enable farms to implement effective preventive measures. The rule requires farms to take timely action based on risk and includes a new requirement for expedited mitigation for certain hazards. The requirements are adaptable to future scientific advancements and provide sufficient flexibility to be practicable for all sizes and types of farms to implement across the wide variety of agricultural water systems, uses, and practices. These revisions to the produce safety regulation will more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness that is a significant public health problem.
78 The Department of Health and Human Services (HHS or the Department) is issuing this final rule regarding section 1557 of the Affordable Care Act (ACA) (section 1557). Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. Section 1557(c) of the ACA authorizes the Secretary of the Department to promulgate regulations to implement the nondiscrimination requirements of section 1557. The Department is also revising its interpretation regarding whether Medicare Part B constitutes Federal financial assistance for purposes of civil rights enforcement. Additionally, the Department is revising provisions prohibiting discrimination on the basis of sex in regulations issued by the Centers for Medicare & Medicaid Services (CMS) governing Medicaid and the Children's Health Insurance Program (CHIP); Programs of All-Inclusive Care for the Elderly (PACE); health insurance issuers and their officials, employees, agents, and representatives; States and the Exchanges carrying out Exchange requirements; agents, brokers, or web-brokers that assist with or facilitate enrollment of qualified individuals, qualified employers, or qualified employees; issuers providing essential health benefits (EHB); and qualified health plan issuers.
79 The Food and Drug Administration (FDA) is amending the food additive regulations to update the production organism Corynebacterium lilium that has been scientifically reclassified to Corynebacterium glutamicum. This action is being taken to improve the accuracy and clarity of the regulations.
80 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Revocation of Uses of Partially Hydrogenated Oils in Foods: Guidance for Industry; Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with our regulations after we revoked specific requirements pertaining to the use of partially hydrogenated oils in certain foods or as a direct or indirect food substance.
81 This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, agent/broker compensation, health equity, dual eligible special needs plans (D-SNPs), utilization management, network adequacy, and other programmatic areas. This final rule also codifies existing sub-regulatory guidance in the Part C and Part D programs.
82 This final rule includes payment parameters and provisions related to the HHS-operated risk adjustment program, as well as 2025 user fee rates for issuers offering qualified health plans (QHPs) through federally facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This final rule also includes requirements related to the auto re-enrollment hierarchy; essential health benefits; failure to file Federal income taxes to reconcile advance payments of the premium tax credit (APTC); non- standardized plan option limits in the FFEs and SBE-FPs and a related exceptions process; standardized plan options in the FFEs and SBE-FPs; special enrollment periods (SEPs); direct enrollment (DE) entities supporting Exchange applications and enrollments; the Insurance Affordability Program enrollment eligibility verification process; requirements for agents, brokers, web-brokers, and DE entities assisting Exchange consumers; network adequacy; public notice procedures for section 1332 waivers; prescription drug benefits; updates to the Consumer Operated and Oriented Plan (CO-OP) Program; and State flexibility on the effective date of coverage in the Basic Health Program (BHP).
83 This document corrects technical errors in the final rule that appeared in the August 7, 2023 Federal Register, entitled "Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2024". The effective date was October 1, 2023.
84 This is the second part of a two-part final rule that simplifies the eligibility and enrollment processes for Medicaid, the Children's Health Insurance Program (CHIP), and the Basic Health Program (BHP). This rule aligns enrollment and renewal requirements for most individuals in Medicaid; establishes beneficiary protections related to returned mail; creates timeliness requirements for redeterminations of eligibility; makes transitions between programs easier; eliminates access barriers for children enrolled in CHIP by prohibiting premium lock-out periods, benefit limitations, and waiting periods; and modernizes recordkeeping requirements to ensure proper documentation of eligibility determinations.
85 The Food and Drug Administration (FDA or we) is amending its regulations relating to the procedures for determining that a premarket notification for a food contact substance (FCN) is no longer effective. The final rule provides additional reasons that could form the basis for FDA to determine that an FCN is no longer effective. The final rule also ensures that manufacturers or suppliers have the opportunity to provide input before we determine that an FCN is no longer effective. We are making these changes to allow FDA to respond better to new information on the safety and use of food contact substances (FCSs), as well as manufacturers' business decisions, and also improve the efficiency of the premarket notification program.
86 The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to update a citation for information collection and conform the regulatory provisions to the Federal Food, Drug, and Cosmetics Act (FD&C Act). The rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors and to ensure accuracy and clarity in the Agency's regulations.
87 The Food and Drug Administration (FDA or we) is revoking the standard of identity and the standard of quality for frozen cherry pie. This action, in part, responds to a citizen petition submitted by the American Bakers Association (ABA). We conclude that these standards are no longer necessary to promote honesty and fair dealing in the interest of consumers. Revocation of the standards of identity and quality for frozen cherry pie will provide greater flexibility in the product's manufacture, consistent with comparable, nonstandardized foods available in the marketplace.
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89 The Food and Drug Administration (FDA or Agency) is amending the standing advisory committee regulations to add the establishment of the Genetic Metabolic Diseases Advisory Committee (GeMDAC or the Committee) to the list of standing committees.
90 This document corrects technical and typographical errors in the final rule that appeared in the December 28, 2023, Federal Register entitled, "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories" (referred to hereafter as the "December 2023 final rule").
91 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2023. The animal drug regulations are also being amended to improve their accuracy and readability.
92 The Food and Drug Administration (FDA or Agency) is amending its regulations to update a link regarding user fee disputes. This technical amendment is non-substantive.
93 This final rule primarily addresses recent legislative changes to the Social Security Act as a result of the Consolidated Appropriations Act, 2021 changes to the hospital-specific limit on Medicaid disproportionate share hospital (DSH) payments. This final rule affords States and hospitals more clarity on how the limit, the changes that took effect on October 1, 2021, will be calculated. Additionally, this final rule enhances administrative efficiency by making technical changes and clarifications to the DSH program.
94 The Food and Drug Administration (FDA or Agency) is amending the standing advisory committees regulations to add the establishment of the Digital Health Advisory Committee (the Committee) to the list of standing advisory committees.
95 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to address the use of master files by applications licensed under the Public Health Service Act (PHS Act). This final rule codifies FDA's existing approach that former approved applications for certain biological products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that have been deemed to be licenses for the biological products under the PHS Act may continue to incorporate by reference drug substance, drug substance intermediate, or drug product (DS/DSI/DP) information contained in a drug master file (DMF) if such information was being referenced at the time the application was deemed to be a license. This final rule also codifies FDA's general practices regarding the referencing of information in master files by applications licensed under the PHS Act, including applications for combination products licensed under the PHS Act, and by investigational new drug applications (INDs) for products that would be subject to licensure under the PHS Act.
96 This document corrects technical and typographical errors in the final rule that appeared in the November 16, 2023 issue of the Federal Register, entitled "Medicare and Medicaid Programs; CY 2024 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Medicare Advantage; Medicare and Medicaid Provider and Supplier Enrollment Policies; and Basic Health Program" (referred to hereafter as the "CY 2024 PFS final rule"). The effective date was January 1, 2024.
97 This document corrects technical and typographical errors in the final rule with comment period that appeared in the Federal Register on November 22, 2023, titled "Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems; Quality Reporting Programs; Payment for Intensive Outpatient Services in Hospital Outpatient Departments, Community Mental Health Centers, Rural Health Clinics, Federally Qualified Health Centers, and Opioid Treatment Programs; Hospital Price Transparency; Changes to Community Mental Health Centers Conditions of Participation, Changes to the Inpatient Prospective Payment System Medicare Code Editor; Rural Emergency Hospital Conditions of Participation Technical Correction" (referred to hereafter as the "CY 2024 OPPS/ASC final rule with comment period").
98 The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Sensient Colors, LLC., proposing that we amend our color additive regulations to provide for the safe use of butterfly pea flower extract in ready-to-eat cereals, crackers and snack mixes, and chips at levels consistent with good manufacturing practice.
99 This final rule will improve the electronic exchange of health care data and streamline processes related to prior authorization through new requirements for Medicare Advantage (MA) organizations, state Medicaid fee-for-service (FFS) programs, state Children's Health Insurance Program (CHIP) FFS programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) issuers on the Federally-facilitated Exchanges (FFEs). This final rule will also add new measures for eligible hospitals and critical access hospitals (CAHs) to report under the Medicare Promoting Interoperability Program and for MIPS eligible clinicians to report under the Promoting Interoperability performance category of the Merit-based Incentive Payment System (MIPS). These policies, taken together, will reduce overall payer and provider burden and improve patient access to health information while continuing CMS's drive toward interoperability in the health care market.
100 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). We are doing so by incorporating by reference an international standard specific for device quality management systems. Through this rulemaking we also establish additional requirements and make conforming edits to clarify the device CGMP requirements for such products. This action will continue our efforts to align our regulatory framework with that used by regulatory authorities in other jurisdictions to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.
101 This document corrects technical and typographical errors in the final rule that appeared in the December 28, 2023, Federal Register entitled, "Clinical Laboratory Improvement Amendments of 1988 (CLIA) Fees; Histocompatibility, Personnel, and Alternative Sanctions for Certificate of Waiver Laboratories" (referred to hereafter as the "December 2023 final rule").
102 This document corrects technical errors in the final rule that appeared in the November 13, 2023 Federal Register titled "Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements" (referred to hereafter as the "CY 2024 HH PPS final rule").
103 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in turkey feed. This action is in response to a food additive petition filed by Kemin Industries, Inc.
104 The Food and Drug Administration (FDA or we) is confirming the effective date of December 4, 2023, for the final rule that appeared in the Federal Register of November 3, 2023, and that amended the color additive regulations to provide for the safe use of jagua (genipin- glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice.
105 This final rule updates the Clinical Laboratory Improvement Amendments of 1988 (CLIA) fees and clarifies the CLIA fee regulations. This final rule implements a process for sustainable funding for the CLIA program through a biennial two-part increase of CLIA fees. We are finalizing the incorporation of limited/specific laboratory fees, including fees for follow-up surveys, substantiated complaint surveys, and revised certificates. We are also finalizing the distribution of the administrative overhead costs of test complexity determination for waived tests and test systems with a nominal increase in Certificate of Waiver (CoW) fees. In addition, we are finalizing the clarification of the methodology used to determine program compliance fees. This final rule ensures the continuing quality and safety of laboratory testing for the public. This final rule also amends histocompatibility and personnel regulations under CLIA to address obsolete regulations and update the regulations to incorporate technological changes. In addition, this final rule amends the provisions governing alternative sanctions (including civil money penalties, a directed plan of correction, a directed portion of a plan of correction, and onsite State monitoring) to allow for the imposition of such sanctions on CoW laboratories.
106 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule: Questions and Answers." We are issuing this small entity compliance guide (SECG) in accordance with the Small Business Regulatory Enforcement Fairness Act to help small businesses understand and comply with the "Direct-to- Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format Final Rule" (CCN Final Rule). The CCN Final Rule modifies FDA regulations to reflect the requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that human prescription drug advertisements presented directly to consumers (DTC) in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads) present the major statement relating to side effects and contraindications (major statement) in a clear, conspicuous, and neutral manner and establishes standards to help ensure this requirement is met. The term "drugs" in this guidance refers to prescription human drug and biological products.
107 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations to implement a provision of the 21st Century Cures Act (Cures Act). This final rule allows an exception from the requirement to obtain informed consent when a clinical investigation poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of human subjects. The final rule permits an institutional review board (IRB) to waive or alter certain informed consent elements or to waive the requirement to obtain informed consent, under limited conditions, for certain FDA-regulated minimal risk clinical investigations.
108 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of calcium formate as a feed acidifying agent, to lower the pH, in complete swine and poultry feeds at levels not to exceed 1.2 percent of the complete feed. This action is in response to a food additive petition filed by LANXESS Corp.
109 The Food and Drug Administration (FDA or we) is confirming the effective date of December 22, 2023, for the final rule that appeared in the Federal Register of August 9, 2023. The direct final rule amends our regulations to no longer provide for the use of partially hydrogenated oils (PHOs) in food given our determination that PHOs are no longer generally recognized as safe (GRAS). The rule also revokes prior sanctions (i.e., pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on our conclusion that these uses of PHOs may be injurious to health. This document confirms the effective date of the direct final rule.
110 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during July, August, and September 2023. The animal drug regulations are also being amended to improve their accuracy and readability.
111 This interim final rule with request for comments (IFC) implements reporting requirements and enforcement authorities in the Social Security Act (the Act) that were added by the Consolidated Appropriations Act, 2023 (CAA, 2023). CMS will use these new enforcement authorities as described in this rule if States fail to comply with the new reporting requirements added by the CAA, 2023 or with Federal Medicaid eligibility redetermination requirements during a timeframe that is generally aligned with the period when States are restoring eligibility and enrollment operations following the end of the Medicaid continuous enrollment condition under the Families First Coronavirus Response Act (FFCRA). The new enforcement authorities include requiring States to submit a corrective action plan, suspending disenrollments from Medicaid for procedural reasons, and imposing civil money penalties (CMPs). They also include applying a reduction to the State-specific Federal Medical Assistance Percentage (FMAP) for failure to meet reporting requirements.
112 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt-- Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to explain the actions a small entity must take to comply with FDA's regulations after recent changes made by our 2021 final rule titled "Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt," 2022 final rule titled "International Dairy Foods Association and Chobani, Inc.: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt," and 2023 final order titled "International Dairy Foods Association: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and Amend the Standard for Yogurt."
113 This document corrects technical errors in the final rule that appeared in the October 11, 2023 Federal Register titled "Medicare Program; Medicare Secondary Payer and Certain Civil Money Penalties".
114 This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for calendar year 2024 based on our continuing experience with these systems. In this final rule, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REHQR) Program. In this final rule, we are also establishing a payment for certain intensive outpatient services under Medicare, beginning January 1, 2024. In addition, this final rule updates and refines requirements for hospitals to make public their standard charge information and enforcement of hospital price transparency. We are finalizing changes to the community mental health center (CMHC) Conditions of Participation (CoPs) to provide requirements for furnishing intensive outpatient (IOP) services, and we are finalizing the proposed personnel qualifications for mental health counselors (MHCs) and marriage and family therapists (MFTs). Additionally, we are finalizing the removal of discussion of the inpatient prospective payment system (IPPS) Medicare Code Editor (MCE) from the annual IPPS rulemakings, beginning with the fiscal year (FY) 2025 rulemaking. Finally, we are finalizing a technical correction to the Rural Emergency Hospital (REH) CoPs under the standard for the designation and certification of REHs.
115 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations concerning direct-to- consumer (DTC) advertisements (ads) for human prescription drugs presented in television or radio format and stating the name of the drug and its conditions of use (DTC TV/radio ads). Specifically, the final rule implements a requirement of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner. As directed by FDAAA, FDA is establishing standards to determine whether the major statement in DTC TV/radio ads is presented in a clear, conspicuous, and neutral manner.
116 This final rule will implement portions of section 6101 of the Patient Protection and Affordable Care Act (Affordable Care Act), which require the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities. It will also finalize definitions of private equity company and real estate investment trust for Medicare provider enrollment purposes.
117 This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; payment for dental services inextricably linked to specific covered medical services; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare and Medicaid provider and supplier enrollment policies, electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act); updates to the Ambulance Fee Schedule regulations and the Medicare Ground Ambulance Data Collection System; codification of the Inflation Reduction Act and Consolidated Appropriations Act, 2023 provisions; expansion of the diabetes screening and diabetes definitions; pulmonary rehabilitation, cardiac rehabilitation and intensive cardiac rehabilitation expansion of supervising practitioners; appropriate use criteria for advanced diagnostic imaging; early release of Medicare Advantage risk adjustment data; a social determinants of health risk assessment in the annual wellness visit and Basic Health Program.
118 This final rule sets forth routine updates to the Medicare home health payment rates for calendar year (CY) 2024 in accordance with existing statutory and regulatory requirements. This rule-- discusses comments received regarding access to home health aide services; implements home health payment-related changes; rebases and revises the home health market basket and revises the labor-related share; codifies statutory requirements for disposable negative pressure wound therapy (dNPWT); and implements the new items and services payment for the home intravenous immune globulin (IVIG) benefit. In addition, it--finalizes changes to the Home Health Quality Reporting Program (HH QRP) requirements and the expanded Home Health Value-Based Purchasing (HHVBP) Model; implements the new Part B benefit for lymphedema compression treatment items, codifies the Medicare definition of brace, and makes other codification changes based on recent legislation; adds an informal dispute resolution (IDR) and special focus program (SFP) for hospice programs; codifies DMEPOS refill policy; and finalizes proposed revisions for Medicare provider and supplier enrollment requirements.
119 The Food and Drug Administration (FDA, Agency, or we) is classifying the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the classification of the container system for the processing and storage of Red Blood Cell components under reduced oxygen conditions. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
120 This document corrects technical errors in the final rule that appeared in the August 28, 2023 Federal Register titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated with Section 1115 Demonstrations in the Medicaid Fraction" (referred to hereafter as the "FY 2024 IPPS/LTCH PPS final rule").
121 This final rule describes the agency's actions on remand from the United States (U.S.) District Court for the District of Columbia to craft a remedy in light of the U.S. Supreme Court's decision in American Hospital Association v. Becerra, 142 S. Ct. 1896 (2022), relating to the adjustment of Medicare payment rates for drugs acquired under the 340B Program from calendar year (CY) 2018 through September 27th of CY 2022.
122 This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2024. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this final rule updates requirements for the ESRD Quality Incentive Program and the ESRD Treatment Choices Model.
123 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of jagua (genipin-glycine) blue as a color additive in various food categories at levels consistent with good manufacturing practice (GMP). We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc. on behalf of Ecoflora SAS (Ecoflora).
124 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements." The guidance document addresses certain requirements that apply to blood establishments that collect blood and blood components, including Source Plasma. Specifically, the guidance explains the conditions under which FDA does not intend to take regulatory action for a blood establishment's failure to comply with certain requirements in FDA's regulations regarding donation suitability, donor eligibility, and quarantine hold for Source Plasma. FDA expects that the compliance policy described in the guidance will increase the availability of blood and blood components, including Source Plasma, while maintaining the health of blood donors and the safety of blood and blood components. The guidance announced in this document finalizes the draft guidance of the same title dated May 2022, and supersedes the guidance entitled "Alternative Procedures for Blood and Blood Components During the COVID-19 Public Health Emergency; Guidance for Industry," dated April 2020.
125 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Prior Notice of Imported Food Questions and Answers (Edition 4): Guidance for Industry." The guidance document updates the current version of the guidance by including three additional questions. One question relates to any effect systems recognition or equivalency determinations have on prior notice requirements. The other two questions relate to FDA's notice to a submitter or transmitter of prior notice of an FDA refusal for inadequate prior notice or hold, if the food article is from a foreign facility that is not registered and addresses the timeframe for making requests for FDA review of such refusal or hold. FDA is also making other technical editorial changes. The guidance announced in this notice finalizes the draft guidance of the same title dated September 13, 2022.
126 This final rule will specify how and when CMS must calculate and impose civil money penalties (CMPs) when group health plan (GHP) and non-group health plan (NGHP) responsible reporting entities (RREs) fail to meet their Medicare Secondary Payer (MSP) reporting obligations by failing to register and report as required by MSP reporting requirements. This final rule will also establish CMP amounts and circumstances under which CMPs will and will not be imposed.
127 This document corrects technical and typographical errors in the final rule that appeared in the August 28, 2023 Federal Register titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2024 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Rural Emergency Hospital and Physician-Owned Hospital Requirements; and Provider and Supplier Disclosure of Ownership; and Medicare Disproportionate Share Hospital (DSH) Payments: Counting Certain Days Associated with Section 1115 Demonstrations in the Medicaid Fraction" (referred to hereafter as the "FY 2024 IPPS/LTCH PPS final rule").
128 This document corrects technical errors in the final rule that appeared in the August 7, 2023 Federal Register, entitled "Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2024" (referred to hereafter as the "FY 2024 SNF final rule"). The effective date of the FY 2024 SNF final rule is October 1, 2023.
129 This document corrects technical errors that appeared in the final rule published in the Federal Register on August 2, 2023 entitled "Medicare Program; FY 2024 Inpatient Psychiatric Facilities Prospective Payment System--Rate Update".
130 This document corrects technical and typographical errors in the final rule that appeared in the August 2, 2023 Federal Register entitled "Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2024 and Updates to the IRF Quality Reporting Program" (referred to hereafter as the "FY 2024 IRF final rule"). The effective date of the FY 2024 IRF final rule is October 1, 2023.
131 The Food and Drug Administration (FDA, the Agency, or we) is correcting the final rule on requirements for additional traceability records for certain foods that published in the Federal Register of November 21, 2022. The final rule published with some editorial and inadvertent errors. This document corrects those errors.
132 This final rule simplifies processes for eligible individuals to enroll and retain eligibility in the Medicare Savings Programs (MSPs). This final rule better aligns enrollment into the MSPs with requirements and processes for other public programs. Finally, this final rule reduces the complexity of applications and reenrollment for eligible individuals.
133 The Food and Drug Administration (FDA or the Agency) is announcing the termination of the Board of Tea Experts by the Federal Tea Tasters Repeal Act of 1996. This document removes the Board of Tea Experts from the Agency's list of standing advisory committees. FDA is also updating the statutory citation to the Federal Advisory Committee Act to reflect recodification. This technical change aligns with the desire of Congress to incorporate various provisions that were enacted separately over a period of years; reorganize them; conforming style and terminology; modernizing obsolete language; and correcting drafting errors to remove ambiguities, contradictions, and other imperfections without changing the meaning of or effect of existing law.
134 The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product--Compliance Policies, Revision 1." This revised guidance explains that FDA intends to extend for an additional year (from November 27, 2023, to November 27, 2024), the enforcement policies described in the guidance entitled "Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product--Compliance Policies," published in the Federal Register on October 23, 2020 (the 2020 Compliance Policies). The 2020 Compliance Policies relate to provisions in the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by the Drug Supply Chain Security Act (DSCSA), requiring wholesale distributors to verify the product identifier prior to further distributing saleable returned product and requiring dispensers to verify the product identifier for suspect or illegitimate product in the dispenser's possession or control.
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136 This document establishes requirements for mandatory annual State reporting of the Core Set of Children's Health Care Quality Measures for Medicaid and the Children's Health Insurance Program (CHIP), the behavioral health measures on the Core Set of Adult Health Care Quality Measures for Medicaid, and the Core Sets of Health Home Quality Measures for Medicaid.
137 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies." This guidance describes FDA's compliance policies regarding enforcement of requirements for the interoperable, electronic, package level product tracing (referred to as enhanced drug distribution security requirements) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that will go into effect on November 27, 2023. FDA believes the compliance policies outlined in this guidance will help supply chain stakeholders, particularly trading partners, by accommodating the additional time that may be needed to continue to develop and refine appropriate systems and processes to conduct interoperable, electronic tracing at the package level, to achieve robust supply chain security under the Drug Supply Chain Security Act (DSCSA) while helping ensure continued patient access to prescription drugs.
138 This final rule will: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs); and make other policy- related changes. This final rule also revises our regulations on the counting of days associated with individuals eligible for certain benefits provided by section 1115 demonstrations in the Medicaid fraction of a hospital's disproportionate patient percentage (DPP) used in the disproportionate share hospital (DSH) calculation.
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140 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during April, May, and June 2023. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve their accuracy and readability.
141 The Food and Drug Administration (FDA or we) is amending our regulations that provide for the use of partially hydrogenated oils (PHOs) in food in light of our determination that PHOs are no longer generally recognized as safe (GRAS). The rule removes PHOs as an optional ingredient in the standards of identity for peanut butter and canned tuna. It revises FDA's regulations affirming food substances as GRAS pertaining to menhaden oil and rapeseed oil to no longer include partially hydrogenated forms of these oils, and deletes the regulation affirming hydrogenated fish oil as GRAS as an indirect food substance. We are also revoking prior sanctions (i.e., pre-1958 authorization of certain uses) for the use of PHOs in margarine, shortening, and bread, rolls, and buns based on our conclusion that these uses of PHOs may be injurious to health. We are issuing these amendments directly as a final rule because they are noncontroversial given the public health risks associated with PHOs and the increasing use of PHO alternatives, and we anticipate no significant adverse comments because PHOs were declared no longer GRAS for any use in human food in 2015.
142 This final rule updates payment rates, including implementing the second phase of the Patient Driven Payment Model (PDPM) parity adjustment recalibration. This final rule also updates the diagnosis code mappings used under PDPM, the SNF Quality Reporting Program (QRP), and the SNF Value-Based Purchasing (VBP) Program. We are also eliminating the requirement for facilities to actively waive their right to a hearing in writing, treating as a constructive waiver when the facility does not submit a request for hearing.
143 This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2024. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2024. It also rebases and revises the IRF market basket to reflect a 2021 base year. It also confirms when IRF units can become excluded and paid under the IRF PPS. This rule also includes updates for the IRF Quality Reporting Program (QRP).
144 This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. Additionally, this final rule rebases and revises the IPF market basket to reflect a 2021 base year. These changes will be effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2023 through September 30, 2024 (FY 2024). In addition, this final rule discusses quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program with changes beginning with the FY 2025 payment determination through changes beginning with the FY 2028 payment determination.
145 This final rule updates the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2024. This rule discusses the comments received regarding information related to the provision of higher levels of hospice care; spending patterns for non-hospice services provided during the election of the hospice benefit; ownership transparency; equipping patients and caregivers with information to inform hospice selection; and ways to examine health equity under the hospice benefit. This rule also finalizes conforming regulations text changes related to the expiration of the COVID-19 public health emergency. In addition, this rule updates the Hospice Quality Reporting Program; discusses the Hospice Outcomes and Patient Evaluation tool; provides an update on Health Equity and future quality measures; and provides updates on the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment. This rule also codifies hospice data submission thresholds and discusses updates to hospice survey and enforcement procedures. Additionally, the rule requires hospice certifying physicians to be Medicare-enrolled or to have validly opted-out.
146 This document corrects a technical error that appeared in the final rule published in the Federal Register on April 12, 2023 titled "Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly."
147 This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment.
148 The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the name of Division of Dockets Management to Dockets Management Staff and information regarding copies. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
149 This final action establishes a policy concerning the treatment of patient days associated with persons enrolled in a Medicare Part C (also known as "Medicare Advantage") plan for purposes of calculating a hospital's disproportionate patient percentage for cost reporting periods starting before fiscal year (FY) 2014 in response to the Supreme Court's ruling in Azar v. Allina Health Services, 139 S. Ct. 1804 (June 3, 2019).
150 This document corrects technical errors that appeared in the final rule published in the Federal Register on April 12, 2023 entitled "Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly."
151 This final rule removes expired language addressing staff and patient COVID-19 testing requirements for LTC Facilities issued in the interim final rule with comment "Medicare and Medicaid Programs, Clinical Laboratory Improvement Amendments (CLIA), and Patient Protection and Affordable Care Act; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency" published in the September 2, 2020 Federal Register. The rule also finalizes requirements for these facilities to provide education about COVID-19 vaccines and to offer COVID-19 vaccines to residents, clients, and staff. In addition, the rule withdraws the regulations in the interim final rule with comment (IFC) "Omnibus COVID-19 Health Care Staff Vaccination" published in the November 5, 2021 Federal Register, and finalizes certain provisions of the "COVID-19 Vaccine Requirements for Long-Term Care (LTC) Facilities and Intermediate Care Facilities for Individuals with Intellectual Disabilities (ICFs-IID) Residents, Clients, and Staff" IFC, published in the May 13, 2021 Federal Register.
152 This document corrects technical errors that appeared in the final rule published in the Federal Register on April 12, 2023, entitled "Contract Year 2024 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly."
153 The Food and Drug Administration is correcting a final rule entitled "Food Labeling, Infant Formula Requirements, Food Additives and Generally Recognized as Safe Substances, New Dietary Ingredient Notification; Technical Amendments" that appeared in the Federal Register of March 24, 2023. The final rule corrected typographical errors, corrected errors in sample labels, restored inadvertent omissions, and updated office and organization names, addresses, and other references. The document was published with an incorrect abbreviation to "Potassium" in the codified language. This document corrects that error.
154 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Requirements for Additional Traceability Records for Certain Foods: What You Need to Know About the FDA Regulation: Guidance for Industry-- Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled "Requirements for Additional Traceability Records for Certain Foods."
155 The Food and Drug Administration (FDA or we) is correcting a final order that appeared in the Federal Register on April 14, 2023. The document responded to objections and requests for a public hearing on the final rule to revoke the standards for lowfat yogurt and nonfat yogurt and amend the standard for yogurt. The final order published with an inadvertent error. This document corrects that error.
156 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during January, February, and March 2023. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve their accuracy and readability.
157 This document is to alert Medicare Diabetes Prevention Program (MDPP) expanded model suppliers and interested parties that although current MDPP flexibilities permitted pursuant to regulations issued during the Public Health Emergency (PHE) for COVID-19 are scheduled to expire on May 11, 2023, we are specifying an effective date, for purposes of the regulations of December 31, 2023, through which in- person delivery of MDPP services can be suspended. This extended effective date applies for all MDPP suppliers to allow additional time to resume in-person services. MDPP suppliers may use all of or part of this period to extend the flexibilities described in the regulations. This document provides information to MDPP suppliers regarding the extension of the ability to suspend in-person services as the PHE for COVID-19 concludes.
158 The Food and Drug Administration (FDA or we) published a final rule entitled "Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt," on June 11, 2021 (the 2021 final rule). The International Dairy Foods Association (IDFA) objected to the final rule's provision that yogurt have either a titratable acidity of not less than 0.7 percent, expressed as lactic acid, or a pH of 4.6 or lower before the addition of bulky flavoring ingredients. We are denying IDFA's request for a public hearing with respect to this objection and are issuing a final order to modify the final rule's provision with respect to both pH and titratable acidity.
159 This final rule will revise the Medicare Advantage (Part C), Medicare Prescription Drug Benefit (Part D), Medicare cost plan, and Programs of All-Inclusive Care for the Elderly (PACE) regulations to implement changes related to Star Ratings, marketing and communications, health equity, provider directories, coverage criteria, prior authorization, passive enrollment, network adequacy, and other programmatic areas. This final rule will also codify regulations implementing section 118 of Division CC of the Consolidated Appropriations Act, 2021, section 11404 of the Inflation Reduction Act, and includes provisions that will codify existing sub-regulatory guidance in the Part C, Part D, and PACE programs.
160 The Food and Drug Administration (FDA or Agency) is issuing a final order to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures, an unclassified, preamendments device following the classification of the device into class III.
161 The Food and Drug Administration (FDA or Agency) is issuing a final rule to classify spinal spheres for use in intervertebral fusion procedures (an unclassified, preamendments device) into class III for which FDA is separately requiring the filing of a premarket approval application (PMA). FDA has determined that general controls and special controls together are insufficient to provide reasonable assurance of safety and effectiveness for this device.
162 The Food and Drug Administration (FDA, Agency, or we) is amending its regulations to update the address, email address, and office name for the Office of Policy, Legislation, and International Affairs, Office of Global Policy and Strategy. This technical amendment is to ensure accuracy and clarity in the Agency's regulations and is nonsubstantive.
163 The Food and Drug Administration (FDA or we) is amending its regulations that pertain to food labeling, infant formula requirements, food additives, direct food substances affirmed as generally recognized as safe (GRAS), and new dietary ingredient (NDI) notifications. These amendments correct typographical errors, correct errors in sample labels, restore inadvertent omissions, and update office and organization names, addresses, and other references. This action is ministerial or editorial in nature.
164 The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to update mailing address and docket number and conform the regulatory provisions to the Federal Food, Drug, and Cosmetics Act (FD&C Act). The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature to correct errors and to ensure accuracy and clarity in the Agency's regulations.
165 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during October, November, and December 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
166 The Food and Drug Administration (FDA) is announcing conforming changes to its regulations issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as required by the Consolidated Appropriations Act of 2022, which amended the term "tobacco product" in the FD&C Act to include products that contain nicotine from any source.
167 The Food and Drug Administration (FDA or we) is confirming the effective date of December 13, 2022, for the final rule that appeared in the Federal Register of November 10, 2022, and that amended the color additive regulations to provide for the safe use of spirulina (Arthrospira platensis) extract as a color additive in alcoholic beverages with less than 20 percent alcohol-by-volume content, non- alcoholic beverages, condiments and sauces, dips, dairy product alternatives (identified as non-dairy yogurt alternatives, non-dairy frozen desserts, and non-dairy puddings), salad dressings, and seasoning mixes (unheated).
168 In the November 18, 2022 issue of the Federal Register, we published a final rule entitled "Medicare and Medicaid Programs; CY 2023 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; Implementing Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs To Provide Refunds With Respect to Discarded Amounts; and COVID- 19 Interim Final Rules" (referred to hereafter as the "CY 2023 PFS final rule"). The effective date was January 1, 2023. This document corrects a limited number of technical and typographical errors identified in the November 18, 2022 final rule.
169 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
170 The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to update the mammography regulations that were issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). We are issuing updates to modernize the regulations by incorporating current science and mammography best practices. These updates are intended to improve the delivery of mammography services by strengthening the communication of healthcare information; allowing for more informed decision making by patients and providers (by requiring facilities to provide them with additional health information); helping to ensure the availability of qualified mammography personnel; bolstering the medical outcomes audit to provide feedback to improve mammography interpretations; modernizing technological aspects of the standards; and adding additional tools to deal with noncompliant facilities.
171 Before using an electronic signature in an electronic record required by the Food and Drug Administration (FDA or Agency), a person must submit a letter of non-repudiation to FDA. Letters of non- repudiation are required to certify that a person's electronic signatures are intended to be the legally binding equivalent of traditional handwritten signatures. FDA is amending its regulations to update the address for submission of a certification in paper form and to provide an option for electronic submission. This amendment is to ensure accuracy and clarity in the Agency's regulations. This technical amendment is nonsubstantive.
172 The Food and Drug Administration (FDA, Agency, or we) is classifying the software algorithm device to assist users in digital pathology into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the software algorithm device to assist users in digital pathology's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
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174 This final rule announces certain policies to improve program integrity and payment accuracy in the Medicare Advantage (MA) program. The purpose of this final rule is to outline our audit methodology and related policies for the contract-level MA Risk Adjustment Data Validation (RADV) program. Specifically, this final rule codifies in regulation that, as part of the RADV audit methodology, CMS will extrapolate RADV audit findings beginning with payment year (PY) 2018 and will not extrapolate RADV audit findings for PYs 2011 through 2017. We are also finalizing a policy whereby CMS will not apply an adjustment factor (known as a Fee-For-Service (FFS) Adjuster) in RADV audits. We are also codifying in regulation the requirement that MA organizations (MAOs) remit improper payments identified during RADV audits in a manner specified by CMS.
175 The Food and Drug Administration (FDA, Agency, or we) is classifying the software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
176 The Food and Drug Administration (FDA or we) is confirming the effective date of October 28, 2022, for the final rule that appeared in the Federal Register of September 27, 2022, and that amended the color additive regulations to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules.
177 The Food and Drug Administration (FDA or Agency) is publishing this notification in light of the recent decision by the U.S. Court of Appeals for the Eleventh Circuit in Catalyst Pharms., Inc. v. Becerra. The Catalyst decision addressed the orphan-drug exclusivity provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Orphan Drug Act and subsequent amendments, and concluded that FDA's approval of Jacobus Pharmaceutical Company's (Jacobus's) drug (the drug at issue in the litigation) must be set aside. Consistent with the court's decision, FDA has set aside its approval of Jacobus's drug. This notification announces that, at this time, while complying with the court's order in Catalyst, FDA intends to continue to apply its regulations tying the scope of orphan-drug exclusivity to the uses or indications for which a drug is approved to matters beyond the scope of that order.
178 The Food and Drug Administration (FDA, Agency, or we) is classifying the computerized behavioral therapy device for treating symptoms of gastrointestinal conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the computerized behavioral therapy device for treating symptoms of gastrointestinal conditions' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
179 The Food and Drug Administration (FDA, Agency, or we) is classifying the intense pulsed light device for managing dry eye into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intense pulsed light device for managing dry eye's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
180 The Food and Drug Administration (FDA, Agency, or we) is amending and repealing parts of the radiological health regulations covering recommendations for radiation protection during medical procedures, certain records and reporting for electronic products, and performance standards for diagnostic x-ray systems and their major components, laser products, and ultrasonic therapy products. The Agency is taking this action to clarify and update the regulations to reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices.
181 The Food and Drug Administration (FDA, Agency, or we) is classifying the prognostic test for assessment of liver related disease progression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the prognostic test for assessment of liver related disease progression's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
182 This document announces updates to the Healthcare Common Procedure Coding System (HCPCS) codes on the Required Face-to-Face Encounter and Written Order Prior to Delivery List.
183 The Food and Drug Administration (FDA, Agency, or we) is classifying the digital therapy device to reduce sleep disturbance for psychiatric conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the digital therapy device to reduce sleep disturbance for psychiatric conditions' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
184 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance entitled "Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Guidance for Industry." This guidance document provides our thinking on how importers of food for humans and animals can comply with the regulation on foreign supplier verification programs (FSVPs) issued on November 27, 2015. The guidance announced in this notice finalizes the draft guidance of the same title dated January 24, 2018.
185 The Food and Drug Administration (FDA, Agency, or we) is classifying the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
186 The Food and Drug Administration (FDA, Agency, or we) is classifying the powered insertion system for a cochlear implant electrode array into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the powered insertion system for a cochlear implant electrode array's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
187 The Food and Drug Administration (FDA, Agency, or we) is classifying the resorbable shoulder spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the resorbable shoulder spacer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
188 The Food and Drug Administration (FDA, Agency, or we) is classifying the electroencephalography (EEG)-driven upper extremity powered exerciser into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the electroencephalography (EEG)-driven upper extremity powered exerciser's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
189 The Food and Drug Administration (FDA, Agency, or we) is classifying the virtual reality behavioral therapy device for pain relief into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the virtual reality behavioral therapy device for pain relief's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
190 The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>3</INF> as a nutrient supplement in breakfast cereals and grain- based bars (e.g., breakfast bars, granola bars, rice cereal bars), and to update the reference for the Vitamin D<INF>3</INF> specifications. We are taking this action in response to a petition filed by Kellogg Company (Kellogg).
191 The Food and Drug Administration (FDA, Agency, or we) is classifying brain stimulation programming planning software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain stimulation programming planning software's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
192 The Food and Drug Administration (FDA, Agency or we) is classifying the implantable post-surgical kinematic measurement knee device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the implantable post-surgical kinematic measurement knee device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
193 The Food and Drug Administration (FDA, Agency, or we) is classifying the bone indentation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the bone indentation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
194 This document corrects technical errors in the final rule with comment period and final rule that appeared in the Federal Register on November 23, 2022, titled "Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID-19."
195 The Food and Drug Administration (FDA or we) is establishing January 1, 2026, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2023, and on or before December 31, 2024. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of labeling changes.
196 The Food and Drug Administration (FDA, Agency, or we) is classifying the gastrointestinal lesion software detection system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the gastrointestinal lesion software detection system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
197 The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric Autism Spectrum Disorder (ASD) diagnosis aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pediatric Autism Spectrum Disorder diagnosis aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
198 This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 3, 2022, entitled "Medicare Program; Implementing Certain Provisions of the Consolidated Appropriations Act, 2021 and other Revisions to Medicare Enrollment and Eligibility Rules."
199 This document corrects technical errors that appeared in the November 7, 2022 Federal Register in the final rule entitled "Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End- Stage Renal Disease Treatment Choices Model" (referred to hereafter as the calendar year (CY) 2023 ESRD PPS final rule).
200 The Food and Drug Administration (FDA, Agency, or we) is classifying the extracorporeal system for carbon dioxide removal into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the extracorporeal system for carbon dioxide removal's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
201 The Food and Drug Administration (FDA, Agency, or we) is classifying the resorbable implant for anterior cruciate ligament (ACL) repair into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the resorbable implant for ACL repair's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
202 The Food and Drug Administration (FDA, Agency or we) is classifying the interventional cardiovascular implant simulation software device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the interventional cardiovascular implant simulation software device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
203 The Food and Drug Administration (FDA, Agency, or we) is classifying the human leukocyte antigen typing companion diagnostic test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the human leukocyte antigen typing companion diagnostic test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
204 The Food and Drug Administration (FDA, Agency, or we) is classifying the adjunctive hemodynamic indicator with decision point into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the adjunctive hemodynamic indicator with decision point's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
205 The Food and Drug Administration is correcting a final rule entitled "International Dairy Foods Association and Chobani, Inc.: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt" that appeared in the Federal Register of December 15, 2022. The final rule revoked the standards of identity for lowfat yogurt and nonfat yogurt and amended the standard of identity for yogurt in numerous respects. The document was published with an errant reference to its effective date in the preamble discussion. This document corrects that error.
206 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Best Practices for Convening a GRAS Panel." This guidance document is intended for any person who is responsible for a conclusion that a substance may be used in food on the basis of the generally recognized as safe (GRAS) provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) when that person convenes a panel of experts ("GRAS panel") to independently evaluate whether the available scientific data, information, and methods establish that the substance is safe under the conditions of its intended use in human food or animal food. This guidance provides our current thinking on best practices to identify GRAS panel members who have appropriate and balanced expertise; to take steps to reduce the risk that bias (or the appearance of bias) will affect the credibility of the GRAS panel's output (often called a "GRAS panel report"), including the assessment of potential GRAS panel members for conflict of interest and the appearance of conflict of interest; and to limit the data and information provided to a GRAS panel to public information (e.g., by not providing the GRAS panel with information such as trade secret information).
207 This rule finalizes the methodology and data sources necessary to determine Federal payment amounts to be made for program year 2023 to States that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Health Insurance Exchanges.
208 The Food and Drug Administration (FDA, Agency, or we) received objections and requests for a hearing from the International Dairy Foods Association (IDFA) and Chobani, Inc. (Chobani) on the final rule titled "Milk and Cream Products and Yogurt Products; Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt," which published on June 11, 2021. The final rule revoked the standards of identity for lowfat yogurt and nonfat yogurt and amended the standard of identity for yogurt in numerous respects. We are denying the requests for a public hearing and modifying the final rule in response to certain objections. Therefore, the stay of the effectiveness for the final regulation is now lifted.
209 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (cNADAs) during April, May, and June 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
210 The Food and Drug Administration (FDA) is confirming the effective date of December 14, 2022, for the final rule that appeared in the Federal Register of September 15, 2022. The direct final rule revises the "small number of animals" definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. This document confirms the effective date of the direct final rule.
211 This document corrects typographical errors in the final rule that appeared in the August 10, 2022, Federal Register as well as an additional typographical error in a related correcting amendment that appeared in the November 4, 2022 Federal Register. The final rule was entitled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non-qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation".
212 As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ("Tobacco Products; Required Warnings for Cigarette Packages and Advertisements"), which published on March 18, 2020. The new effective date is November 6, 2023.
213 This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2023 based on our continuing experience with these systems. We describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program; the ASC Quality Reporting (ASCQR) Program; and the Rural Emergency Hospital Quality Reporting (REH) Program. We also make updates to the requirements for Organ Acquisition, REHs, Prior Authorization, and Overall Hospital Quality Star Rating. We are establishing a new provider type for REHs, and we are finalizing proposals regarding payment policy, quality measures, and enrollment policy for REHs. In addition, we are finalizing the Conditions of Participation that REHs must meet in order to participate in the Medicare and Medicaid programs. This rule also finalizes changes to the Critical Access Hospitals (CAH) CoPs for the location and distance requirements, patient's rights requirements, and flexibilities for CAHs that are part of a larger health system. Finally, we are finalizing as implemented a number of provisions included in the COVID-19 interim final rules with comment period (IFCs).
214 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule establishing additional recordkeeping requirements for persons who manufacture, process, pack, or hold foods the Agency has designated for inclusion on the Food Traceability List (FTL). The final rule adopts provisions requiring these entities to maintain records containing information on critical tracking events in the supply chain for these designated foods, such as initially packing, shipping, receiving, and transforming these foods. The requirements established in the final rule will help the Agency rapidly and effectively identify recipients of foods to prevent or mitigate foodborne illness outbreaks and address credible threats of serious adverse health consequences or death resulting from foods being adulterated or misbranded. We are issuing this regulation in accordance with the FDA Food Safety Modernization Act (FSMA).
215 This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare and Medicaid provider enrollment policies, including for skilled nursing facilities; updates to conditions of payment for DMEPOS suppliers; HCPCS Level II coding and payment for wound care management products; electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan or an MA-PD plan under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act (SUPPORT Act); updates to the Medicare Ground Ambulance Data Collection System; provisions under the Infrastructure Investment and Jobs Act; and finalizes the CY 2022 Methadone Payment Exception for Opioid Treatment Programs IFC. We are also finalizing, as implemented, a few provisions included in the COVID-19 interim final rules with comment period.
216 In the July 11, 2022 issue of the Federal Register, we published a final rule that updated proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. The effective date was August 10, 2022, except for the amendments in amendatory instructions 2 and 5 through 21, which are effective July 11, 2024. This document corrects one technical error identified in the July 11, 2022 final rule.
217 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina (Arthrospira platensis) extract as a color additive in alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, condiments and sauces, dips, dairy product alternatives (identified as non-dairy yogurt alternatives, non-dairy frozen desserts, and non-dairy puddings), salad dressings, and seasoning mixes (unheated). This action is in response to a color additive petition (CAP) filed by GNT USA, Inc. (GNT).
218 This final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2023. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule updates requirements for the ESRD Quality Incentive Program and finalizes changes to the ESRD Treatment Choices Model.
219 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to premarket notification. Through this final order, FDA is also adding a new device classification regulation along with special controls that are necessary to provide a reasonable assurance of safety and effectiveness for this device type. The final order reclassifies this device type from class III (premarket approval) to class II (special controls) and will reduce the regulatory burdens associated with these devices because manufacturers will no longer be required to submit a premarket approval application (PMA) for this device type but can instead submit a less burdensome premarket notification (510(k)) and receive clearance before marketing their device.
220 This document corrects technical and typographical errors in the final rule that appeared in the August 10, 2022 Federal Register. The final rule was titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2023 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Costs Incurred for Qualified and Non- qualified Deferred Compensation Plans; and Changes to Hospital and Critical Access Hospital Conditions of Participation".
221 This final rule sets forth routine updates to the Medicare home health payment rates for calendar year (CY) 2023 in accordance with existing statutory and regulatory requirements. This final rule also finalizes a methodology for determining the impact of the difference between assumed versus actual behavior change on estimated aggregate expenditures for home health payments as result of the change in the unit of payment to 30 days and the implementation of the Patient Driven Groupings Model (PDGM) case-mix adjustment methodology and finalizes a corresponding permanent prospective adjustment to the CY 2023 home health payment rate. This rule finalizes the reassignment of certain diagnosis codes under the PDGM case-mix groups, and establishes a permanent mitigation policy to smooth the impact of year-to-year changes in home health payments related to changes in the home health wage index. This rule also finalizes recalibration of the PDGM case-mix weights and updates the low utilization payment adjustment (LUPA) thresholds, functional impairment levels, comorbidity adjustment subgroups for CY 2023, and the fixed-dollar loss ratio (FDL) used for outlier payments. Additionally, this rule discusses comments received on the future collection of data regarding the use of telecommunications technology during a 30-day home health period of care on home health claims. This rule also finalizes changes to the Home Health Quality Reporting Program (HH QRP) requirements; changes to the expanded Home Health Value-Based Purchasing (HHVBP) Model; and updates to the home infusion therapy services payment rates for CY 2023.
222 This final rule implements certain provisions of the Consolidated Appropriations Act, 2021 (CAA). Additionally, we are proposing to delete references to specific Medicare forms from the text of existing regulations at Sec. Sec. 406.7 and 407.11 in order to provide greater administrative flexibility. Finally, this final rule updates the various federal regulations that affect a State's payment of Medicare Part A and B premiums for beneficiaries enrolled in the Medicare Savings Programs and other Medicaid eligibility groups.
223 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance entitled "Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps): Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entity establishments that manufacture HCT/Ps better understand the comprehensive regulatory framework for HCT/Ps set forth in the regulations and comply with certain HCT/P- related final rules. The SECG announced in this notice supersedes the SECG of the same title dated August 2007.
224 The Food and Drug Administration (FDA or we) is announcing the effective date for requirements related to establishing and implementing supply-chain programs, records documenting supply-chain programs, and onsite audits in two final rules, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, that appeared in the Federal Register of September 17, 2015.
225 The Food and Drug Administration (FDA or the Agency) is extending the period before FDA intends to begin enforcing the statutory 5 percent limit on distribution of compounded human drug products out of the State in which they are compounded in States that have not entered into a standard memorandum of understanding (MOU) with FDA addressing certain distributions of compounded human drug products. FDA is extending the period, which was scheduled to end on October 27, 2022, until the effective date of a final rule regarding certain distributions of compounded human drug products and publication of an updated standard MOU.
226 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Laboratory Accreditation for Analyses of Foods: What You Need to Know About the FDA Regulation: Guidance for Industry--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled "Laboratory Accreditation for Analyses of Foods."
227 The Food and Drug Administration (FDA, the Agency, or we), with the Department of the Treasury's concurrence, is amending its regulations to require that certain data elements be submitted for veterinary devices that are being imported or offered for import in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by U.S. Customs and Border Protection (CBP), in order for CBP to process the filing and to help FDA in determining the admissibility of those veterinary devices. This final rule will make the submission of the general data elements currently required to be submitted in ACE for other FDA-regulated products at the time of entry also required in ACE for veterinary devices being imported or offered for import into the United States. This final rule will increase effective and efficient admissibility review by FDA of those entry lines containing a veterinary device, which will protect public health by allowing the Agency to focus its limited resources on FDA-regulated products that may be associated with a greater public health risk.
228 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2022. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.
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230 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate in dietary supplement tablets and capsules. We are taking this action in response to a color additive petition (CAP) submitted by Colorcon, Inc. (Colorcon or petitioner).
231 On November 6, 2020, CMS published an interim final rule with request for comments (IFR) entitled "Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency." The IFR set forth certain requirements in CMS regulations that States must follow in order to claim a temporary increase in Federal matching funds for their Medicaid programs under the Families First Coronavirus Response Act (FFCRA). In light of the possibility of changed circumstances since publication of the IFR and other policy considerations, CMS is considering modifying those requirements. CMS is soliciting additional information from the public on any issues that may be pertinent to these potential modifications by reopening the public comment period for an additional 30 days.
232 The Food and Drug Administration (FDA, the Agency, or we) is revising the "small number of animals" definition for dogs and cats in our existing regulation for new animal drugs for minor use or minor species. The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) provides incentives to encourage animal drug sponsors to develop and seek FDA approval of drugs intended for use in minor animal species or for minor uses in major animal species. Congress provided a statutory definition of "minor use" that relies on the phrase "small number of animals" to characterize such use. We are revising the definition of "small number of animals" based on our most recent reassessment of the small numbers, which we conducted from 2018 to 2019.
233 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to specify the deadline and content for submission of an annual summary of investigational drugs supplied under the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act) and the uses for which the investigational drugs were supplied. This final rule implements a provision in the Right to Try Act that requires sponsors and manufacturers who provide an "eligible investigational drug" under the provisions of the Right to Try Act to submit to FDA an annual summary of such use, and directs FDA to specify by regulation the deadline of submission.
234 The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending its public information regulations. The final rule revises the current regulations to incorporate changes made to the Freedom of Information Act (FOIA) by the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act) and the FOIA Improvement Act of 2016 (FOIA Improvement Act). Additionally, the final rule updates the current regulations to reflect changes to the organizational structure of FDA, to make the FOIA process easier for the public to navigate, and to make provisions clearer.
235 The Food and Drug Administration (FDA or we) is confirming the effective date of June 10, 2022, for the final rule that appeared in the Federal Register of May 10, 2022, and that amended the color additive regulations to provide for the safe use of Antarctic krill meal, composed of the ground and dried tissue of Euphausia superba, with or without the lipid fraction, for use in the feed of salmonid fish, to enhance the color of their flesh.
236 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of fumonisin esterase to degrade fumonisins present in poultry feed. This action is in response to a food additive petition filed by Biomin Holding GmbH.
237 We are finalizing our proposal to delay the current start date of the RO Model to a date to be determined through future rulemaking, and to modify the definition of the model performance period to provide that the start and end dates of the model performance period for the RO Model will be established in future rulemaking.
238 As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ("Tobacco Products; Required Warnings for Cigarette Packages and Advertisements"), which published on March 18, 2020. The new effective date is October 6, 2023.
239 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products." This guidance document is intended to describe hearing aids, personal sound amplification products (PSAPs), their respective intended uses, and the regulatory requirements that apply to these products. The FDA Reauthorization Act of 2017 (FDARA) directed FDA to update and finalize the draft guidance entitled "Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products," issued on November 7, 2013. This final guidance fulfills this FDARA requirement and supersedes "Guidance for Industry and FDA Staff: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products," dated February 25, 2009.
240 The Food and Drug Administration (FDA, we, or the Agency) is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, we define OTC hearing aids and establish applicable requirements; amend existing rules for consistency with the new OTC category; repeal the conditions for sale applicable to hearing aids; amend the existing labeling requirements for hearing aids; and update regulations relating to decisions on applications for exemption from Federal preemption that will become obsolete as a result of changes to the hearing aid requirements. In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health.
241 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Access to Areas Outside the Poultry House): Questions and Answers Regarding the Final Rule." The guidance is intended to provide information to egg producers on certain provisions contained in FDA's final rule entitled "Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation" (the egg rule) that reference the "poultry house." Specifically, the document provides guidance to shell egg producers whose production systems provide laying hens with access to areas outside of a "poultry house" as that term is defined in the egg rule.
242 This document announces the suspension of prior authorization for specified orthoses items on the Required Prior Authorization List that require prior authorization as a condition of payment under certain circumstances when reported with certain modifiers. Items subject to face-to-face encounter and written order prior to delivery requirements are not impacted by this document.
243 This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment.
244 This final rule will: revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals; make changes relating to Medicare graduate medical education (GME) for teaching hospitals; update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs). In addition it will establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare Promoting Interoperability Program; and update policies for the Hospital Readmissions Reduction Program, Hospital Inpatient Quality Reporting (IQR) Program, Hospital VBP Program, Hospital- Acquired Condition (HAC) Reduction Program, PPS-Exempt Cancer Hospital Reporting (PCHQR) Program, and the Long-Term Care Hospital Quality Reporting Program (LTCH QRP). It will also revise the hospital and critical access hospital (CAH) conditions of participation (CoPs) for infection prevention and control and antibiotic stewardship programs; and codify and clarify policies related to the costs incurred for qualified and non-qualified deferred compensation plans. Lastly, this final rule will provide updates on the Rural Community Hospital Demonstration Program and the Frontier Community Health Integration Project.
245 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of fumonisin esterase to degrade fumonisins present in swine feed. This action is in response to a food additive petition filed by Biomin GmbH.
246 This final rule updates payment rates; forecast error adjustments; diagnosis code mappings; the Patient Driven Payment Model (PDPM) parity adjustment; the SNF Quality Reporting Program (QRP); and the SNF Value-Based Purchasing (VBP) Program. It also establishes a permanent cap policy to smooth the impact of year-to-year changes in SNF payments related to changes in the SNF wage index. We also announce the application of a risk adjustment for the SNF Readmission Measure for COVID-19 beginning in FY 2023. We are finalizing changes to the long-term care facility fire safety provisions referencing the National Fire Protection Association (NFPA)[supreg] Life Safety Code, and Director of Food and Nutrition Services requirements.
247 This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2023. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2023. In addition, this final rule codifies CMS' existing teaching status adjustment policy through amendments to the regulation text and updates and clarifies the IRF teaching policy with respect to IRF hospital closures and displaced residents. This rule establishes a permanent cap policy to smooth the impact of year-to-year changes in IRF payments related to decreases in the IRF wage index. This final rule also includes updates for the IRF Quality Reporting Program (QRP).
248 This rule updates the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year (FY) 2023. This final rule establishes a permanent mitigation policy to smooth the impact of year- to-year changes in hospice payments related to changes in the hospice wage index. In addition, this rule updates the Hospice Quality Reporting Program (HQRP) and discusses further development of the Hospice Outcomes and Patient Evaluation (HOPE) assessment instrument; updates the Quality Measures (QMs) that will be in effect in FY 2023 for the HQRP and future QMs; updates the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment, discusses a request for information on health equity, and updates the hospice survey and enforcement procedures.
249 This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This final rule establishes a permanent mitigation policy to smooth the impact of year- to-year changes in IPF payments related to decreases in the IPF wage index. In addition, this final rule includes responses to public comments received on the results of the data analysis of the IPF Prospective Payment System (PPS) adjustments. These changes will be effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2022, through September 30, 2023 (FY 2023). Lastly, this final rule includes public comments received in response to requests for information that appeared in the FY 2023 IPF PPS proposed rule.
250 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices." This guidance updates the previous version of the guidance, "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking," issued July 1, 2020. This final guidance explains FDA's compliance policy regarding Global Unique Device Identification Database (GUDID) submission requirements for certain class I devices considered consumer health products and describes how a labeler of a class I devices can determine if its device is one of these devices. Additionally, the guidance explains that FDA intends to extend our existing compliance policy regarding GUDID submission requirements for class I and unclassified devices, other than implantable, life-supporting, or life- sustaining (I/LS/LS) devices, for an additional 75 calendar days.
251 This advisory is to inform potential Enhancing Oncology Model (EOM) applicants and participants that the Merit-based Incentive Payment System (MIPS) payment adjustment factors will not apply to Monthly Enhanced Oncology Services (MEOS) payments in EOM.
252 This final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. This final rule also makes technical changes to PT referral regulations to better align them with the CLIA statute.
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254 This document corrects technical errors that appeared in the final rule published in the Federal Register on April 29, 2022 entitled "Accrediting Organizations--Changes of Ownership."
255 The Food and Drug Administration (FDA or we) is classifying the intravascular bleed monitor into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intravascular bleed monitor's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
256 The Food and Drug Administration (FDA, Agency, or we) is classifying the non-implanted electrical stimulation device for management of premature ejaculation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non- implanted electrical stimulation device for management of premature ejaculation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
257 The Food and Drug Administration (FDA or we) is classifying the coronary artery disease risk indicator using acoustic heart signals into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the coronary artery disease risk indicator using acoustic heart signals' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
258 As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ("Tobacco Products; Required Warnings for Cigarette Packages and Advertisements"), which published on March 18, 2020. The new effective date is July 8, 2023.
259 The Department of Health and Human Services (HHS or Department) is issuing a final rule withdrawing a rule entitled "Securing Updated and Necessary Statutory Evaluations Timely" (SUNSET final rule), which published in the Federal Register of January 19, 2021. The SUNSET final rule was originally scheduled to take effect on March 22, 2021. However, after a lawsuit was filed on March 9, 2021, seeking to overturn the SUNSET final rule, HHS extended the effective date of the SUNSET final rule until September 22, 2022. HHS is now withdrawing the SUNSET final rule.
260 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Importation of Prescription Drugs Final Rule Questions and Answers." The guidance is intended to help small entities comply with the final rule entitled "Importation of Prescription Drugs." The final rule was issued to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada.
261 The Food and Drug Administration (FDA or we) is amending the food additive regulations to no longer provide for the use of 25 plasticizers in various food contact applications because these uses have been abandoned. We are taking this action in response to a food additive petition submitted by the Flexible Vinyl Alliance (FVA or petitioner).
262 The Food and Drug Administration (FDA, we, or the Agency) is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to premarket notification. Through this final order, FDA is also adding two new device classification regulations and identifying special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these device types. This final order will reduce the regulatory burdens associated with these device types, as manufacturers will no longer be required to submit a premarket approval application (PMA) but can instead submit a premarket notification (510(k)) and receive clearance before marketing their device.
263 This final rule reinterprets the scope of the general requirement that State payments for Medicaid services under a State plan must generally be made directly to the individual practitioner or institution providing services or to the beneficiary, in the case of a class of practitioners for which the Medicaid program is the primary source of revenue. Specifically, this final rule explicitly authorizes States to make payments to third parties on behalf of individual practitioners, for individual practitioners' health insurance and welfare benefits, skills training, and other benefits customary for employees, if the individual practitioner consents to such payments on their behalf.
264 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of Antarctic krill meal, composed of the ground and dried tissue of Euphausia superba, with or without the lipid fraction, for use in the feed of salmonid fish, to enhance the color of their flesh. We are taking this action in response to a color additive petition (CAP) submitted by Aker BioMarine Antarctic AS (Aker BioMarine or petitioner).
265 This final rule will revise the Medicare Advantage (MA) (Part C) program and Medicare Prescription Drug Benefit (Part D) program regulations to implement changes related to marketing and communications, past performance, Star Ratings, network adequacy, medical loss ratio reporting, special requirements during disasters or public emergencies, and pharmacy price concessions. This final rule will also revise regulations related to dual eligible special needs plans (D-SNPs), other special needs plans, and cost contract plans. This final rule finalizes certain 2021 and 2022 Star Ratings provisions that were included in two interim final rules with comment period (IFC) that CMS issued on April 6, 2020, and September 2, 2020; other policies from those interim final rules will be addressed in other rulemakings.
266 The Food and Drug Administration (FDA, Agency, or we) is classifying the reverse central venous recanalization system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the reverse central venous recanalization system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
267 The Food and Drug Administration (FDA, Agency, or we) is classifying the magnetically maneuvered capsule endoscopy system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the magnetically maneuvered capsule endoscopy system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
268 The Food and Drug Administration (FDA, Agency, or we) is classifying the mountable electromechanical surgical system for transluminal approaches into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the mountable electromechanical surgical system for transluminal approaches' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
269 This final rule adds new requirements and a specified process to address change of ownership (CHOW) for Accrediting Organizations (AOs) in regard to the transfer of the existing Centers for Medicare & Medicaid Services (CMS) approval for the AO's accreditation programs to the new AO owner. These regulations are intended to provide CMS with the ability to receive notice when an AO is undergoing or negotiating a CHOW, as well as to review the prospective new AO owner's capability to perform its tasks after a CHOW has occurred, in order to ensure the ongoing effectiveness of the transferred accreditation program(s) and to minimize risk to patient safety.
270 The Food and Drug Administration (FDA or we) is classifying the autofluorescence detection device for general surgery and dermatological use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the autofluorescence detection device for general surgery and dermatological use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
271 The Food and Drug Administration (FDA or we) is revising the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride in excess of 0.7 milligrams per liter (mg/L), which available data suggests provides an optimal balance between the prevention of dental caries and the risk of dental fluorosis. This final rule revises the current allowable levels, which range from 0.8 to 1.7 mg/L, for fluoride in domestically packaged and imported bottled water to which fluoride is added. We are taking this action to make the quality standard regulation for fluoride added to bottled water consistent with the 2015 recommendation by the U.S. Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action will not affect the allowable levels for fluoride in bottled water to which fluoride is not added by the manufacturer (such bottled water may contain fluoride from its source water).
272 This final rule with comment period (FC) will finalize the two remaining proposals from the proposed rule titled "Medicare and Medicaid Programs; Contract Year 2021 and 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly" which appeared in the Federal Register on February 18, 2020 (February 2020 proposed rule). The two proposals being finalized here from the February 2020 proposed rule include the maximum out-of-pocket (MOOP) limits for Medicare Parts A and B services and cost sharing limits for Medicare Parts A and B services, including service category cost sharing limits and per member per month actuarial equivalence cost sharing. In addition, CMS is requesting comments in section III of this FC on new or different ways to update and change cost sharing limits in future years for service categories subject to the regulations, including mental health services.
273 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of methyl esters of conjugated linoleic acid for early lactation dairy cows to reduce the energy concentration in milk. This action is in response to a food additive petition filed by BASF Corp.
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275 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.
276 The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations to update mailing address information and to reduce (from three to one) the number of copies of certain documents that need to be submitted to FDA. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations, and to remove a submission requirement that is no longer necessary.
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278 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR part 4." This guidance describes FDA's compliance policy with respect to the requirements of FDA regulations that are now applicable to ophthalmic drugs that are packaged with eye cups, eye droppers, and other dispensers intended for ophthalmic use.
279 The Food and Drug Administration (FDA or Agency) is amending the standing advisory committees' regulations to change the name and function of the Bone, Reproductive and Urologic Drugs Advisory Committee. This action is being taken to reflect changes made to the charter for this advisory committee.
280 The Food and Drug Administration (FDA or we) is providing notice of a stay of the effectiveness of certain provisions of a final rule published in the Federal Register of June 11, 2021. The final rule amended the definition and standard of identity for yogurt and revoked the definitions and standards of identity for lowfat yogurt and nonfat yogurt. FDA is publishing this notification in response to objections timely filed in accordance with regulatory requirements.
281 The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry entitled "Current Good Manufacturing Practice and Preventive Controls, Foreign Supplier Verification Programs, Intentional Adulteration, and Produce Safety Regulations: Enforcement Policy Regarding Certain Provisions." This guidance states Agency policy regarding enforcement of certain requirements related to supply-chain programs for contract manufacturers/processors, the intentional adulteration regulation, and supplier approval and verification requirements in the Current Good Manufacturing Practice and Preventive Controls Regulations and the Foreign Supplier Verification Programs (FSVP) Regulation.
282 The Food and Drug Administration (FDA or we) is classifying the interoperable automated glycemic controller into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the interoperable automated glycemic controller's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
283 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry and FDA staff entitled "Initiation of Voluntary Recalls Under 21 CFR part 7, subpart C." The guidance for industry and FDA staff provides guidance on timely initiation of voluntary recalls of FDA-regulated products. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. In addition, the guidance discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other laws administered by FDA. This guidance finalizes the draft guidance of the same title issued on April 24, 2019.
284 The Department of Health and Human Services (HHS or Department) is postponing, pending judicial review, the effective date of a final rule entitled "Securing Updated and Necessary Statutory Evaluations Timely" (SUNSET final rule) and published in the Federal Register of January 19, 2021, and a final rule correction published in the Federal Register of March 23, 2021.
285 The Food and Drug Administration (FDA, Agency, or we) is classifying the screw sleeve bone fixation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the screw sleeve bone fixation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
286 As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ("Tobacco Products; Required Warnings for Cigarette Packages and Advertisements"), which published on March 18, 2020. The new effective date is April 9, 2023.
287 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and a conditionally approved new animal drug application (cNADA) during July, August, and September 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy of the regulations.
288 The Food and Drug Administration (FDA, Agency, or we) is classifying the integrated continuous glucose monitoring system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the integrated continuous glucose monitoring system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
289 The Food and Drug Administration (FDA or we) is classifying the percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
290 The Food and Drug Administration (FDA or we) is classifying the electromechanical tear stimulator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the electromechanical tear stimulator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
291 The Food and Drug Administration (FDA or we) is classifying the adjunctive predictive cardiovascular indicator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the adjunctive predictive cardiovascular indicator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
292 The Food and Drug Administration (FDA, the Agency, or we) is classifying the spore test strip into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the spore test strip's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
293 In the November 19, 2021 issue of the Federal Register, we published a final rule entitled "Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post-Payment Medical Review Requirements" (referred to hereafter as the "CY 2022 PFS final rule"). The effective date was January 1, 2022. This document corrects a limited number of technical and typographical errors identified in the November 19, 2021 final rule.
294 The Food and Drug Administration (FDA or we) is classifying the system for detection of microorganisms and antimicrobial resistance using reporter expression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the system for detection of microorganisms and antimicrobial resistance using reporter expression's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
295 The Food and Drug Administration (FDA, Agency, or we) is classifying the photoplethysmograph analysis software for over-the- counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the photoplethysmograph analysis software for over-the-counter use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
296 The Food and Drug Administration (FDA or we) is classifying the carbon dioxide gas controlled tissue expander into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the carbon dioxide gas controlled tissue expander's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
297 The Food and Drug Administration (FDA, Agency, or we) is classifying the alternate controller enabled infusion pump into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the alternate controller enabled infusion pump's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
298 The Food and Drug Administration (FDA or we) is correcting a final rule that appeared in the Federal Register on December 3, 2021. The document amended our regulations to establish a program for the testing of food in certain circumstances by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act. The final rule published with some editorial and inadvertent errors. This document corrects those errors.
299
300 The Food and Drug Administration (FDA, Agency, or we) is classifying the retinal diagnostic software device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the retinal diagnostic software device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
301 The Food and Drug Administration (FDA, Agency, or we) is classifying the electrocardiograph software for over-the-counter use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the electrocardiograph software for over-the- counter use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
302 The Food and Drug Administration (FDA or we) is amending the requirements that specify the analytical method FDA uses to determine the concentration of sulfites in food. This action, among other things, provides a new analytical method that can be used as an alternative to the existing analytical method and will help improve the efficiency of FDA testing for sulfites in food.
303 This document announces the updated Healthcare Common Procedure Coding System (HCPCS) codes on the Master List of DMEPOS Items Potentially Subject to Face-to-Face Encounter and Written Order Prior to Delivery and/or Prior Authorization Requirements. It also announces the initial selection of HCPCS codes on the Required Face-to- Face Encounter and Written Order Prior to Delivery List and the updates the HCPCS codes on the Required Prior Authorization List.
304 The Food and Drug Administration (FDA or we) is revoking the standard of identity for French dressing. This action, in part, responds to a citizen petition submitted by the Association for Dressings and Sauces (ADS). We conclude that this standard no longer promotes honesty and fair dealing in the interest of consumers. Revocation of the standard of identity for French dressing will provide greater flexibility in the product's manufacture, consistent with comparable, nonstandardized foods available in the marketplace.
305 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the medical device regulations regarding the procedures for the announcement of approvals and denials of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs). This final rule discontinues the publication in the Federal Register after each quarter of a list of PMA and HDE approvals and denials announced in that quarter. We will continue to post approval and denial notices for PMAs and HDEs on FDA's home page on the internet and will also continue to make available on the internet and place on public display summaries of safety and effectiveness data (SSED) for PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA is taking this action to improve the efficiency of announcing approvals and denials of PMAs and HDEs and to eliminate duplication in the current process for announcing this information. We are also updating Agency contact information and statutory references in certain sections of the PMA and HDE regulations for purposes of accuracy, clarity, and consistency.
306 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revoke the regulations for human tissue intended for transplantation and human dura mater recovered prior to May 25, 2005. The revocation does not affect the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps) recovered on or after May 25, 2005. The rule is being finalized because these regulations are obsolete or no longer necessary to achieve public health goals.
307 This document corrects technical errors in the final rule with comment period that appeared in the Federal Register on November 16, 2021, titled "Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Price Transparency of Hospital Standard Charges; Radiation Oncology Model."
308
309 The Food and Drug Administration (FDA or we) is confirming the effective date of October 5, 2021, for the final rule that appeared in the Federal Register of September 2, 2021, and that amended the color additive regulations to provide for the safe use of butterfly pea flower extract in various food categories at levels consistent with good manufacturing practice.
310 The Food and Drug Administration (FDA or we) is confirming the effective date of November 8, 2021, for the final rule that appeared in the Federal Register of October 6, 2021, and that amended the color additive regulations to provide for the safe use of silver nitrate as a color additive in professional-use only cosmetics to color eyebrows and eyelashes.
311 The Food and Drug Administration (FDA or we) is classifying the transcutaneous electrical continence device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the transcutaneous electrical continence device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
312 The Food and Drug Administration (FDA or we) is classifying the diagnostic neurosurgical microscope filter into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the diagnostic neurosurgical microscope filter's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
313 The Food and Drug Administration (FDA or we) is classifying the cerebrospinal fluid shunt system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cerebrospinal fluid shunt system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
314 This final rule rescinds the Most Favored Nation Model interim final rule with comment period that appeared in the November 27, 2020, Federal Register.
315 This final rule establishes methodologies for adjusting the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule amounts using information from the Medicare DMEPOS competitive bidding program (CBP) for items furnished on or after the effective date specified in the DATES section of this final rule, or the date immediately following the duration of the emergency period described in the Social Security Act (the Act), whichever is later. This final rule also establishes procedures for making benefit category and payment determinations for new items and services that are durable medical equipment (DME), prosthetic devices, orthotics and prosthetics, therapeutic shoes and inserts, surgical dressings, or splints, casts, and other devices used for reductions of fractures and dislocations under Medicare Part B. In addition, this rule classifies continuous glucose monitors (CGMs) as DME under Medicare Part B. Lastly, this final rule finalizes certain DME fee schedule-related provisions that were included in two interim final rules with comment period (IFC) that CMS issued on May 11, 2018, and May 8, 2020.
316 The Food and Drug Administration (FDA or we) is classifying the retrograde intubation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the retrograde intubation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
317 This document corrects technical errors that appeared in the final rule published in the Federal Register on November 19, 2021 entitled "Medicare Program; CY 2022 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Provider Enrollment Regulation Updates; and Provider and Supplier Prepayment and Post- Payment Medical Review Requirements" (referred to hereafter as the "CY 2022 PFS final rule"). The effective date of the CY 2022 PFS final rule is January 1, 2022.
318 This final rule with comment period finalizes certain provisions of the fiscal year 2022 IPPS/LTCH PPS proposed rule. These provisions implement policies based on legislative changes relative to Medicare graduate medical education (GME) for teaching hospitals provided by sections 126, 127, and 131 of the Consolidated Appropriations Act (CAA), 2021; and changes, clarifications, and codifications for Medicare organ acquisition payment policies relative to organ procurement organizations (OPOs), transplant hospitals, and donor community hospitals. In addition, this final rule with comment period solicits comments on certain GME issues to inform potential future rulemaking
319 This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 9, 2021 titled "Medicare and Medicaid Programs; CY 2022 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model Requirements and Model Expansion; Home Health and Other Quality Reporting Program Requirements; Home Infusion Therapy Services Requirements; Survey and Enforcement Requirements for Hospice Programs; Medicare Provider Enrollment Requirements; and COVID-19 Reporting Requirements for Long-Term Care Facilities".
320 The Food and Drug Administration (FDA or we) is classifying the manual percutaneous surgical set assembled in the abdomen into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the manual percutaneous surgical set assembled in the abdomen's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
321 This document corrects technical errors in the final rule that appeared in the November 19, 2021 Federal Register entitled, "Medicaid Program; Delay of Effective Date for Provision Relating to Manufacturer Reporting of Multiple Best Prices Connected to a Value Based Purchasing Arrangement; Delay of Inclusion of Territories in Definition of States and United States."
322 The Food and Drug Administration (FDA or we) is classifying the traumatic brain injury eye movement assessment aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the traumatic brain injury eye movement assessment aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
323 The Food and Drug Administration (FDA or we) is classifying the nonimplanted nerve stimulator for functional abdominal pain relief into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the nonimplanted nerve stimulator for functional abdominal pain relief's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
324 The Food and Drug Administration (FDA or we) is classifying the endoscopic transhepatic venous access needle into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic transhepatic venous access needle's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
325 This document corrects a typographic error that appeared in the final rule published in the Federal Register on November 8, 2021 entitled "Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model."
326 The Food and Drug Administration (FDA or we) is classifying the temporary coil embolization assist device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary coil embolization assist device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
327 The Food and Drug Administration (FDA or we) is classifying the pressure ulcer management tool into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
328 This notification is to inform the public that CMS is exercising its discretion in how it enforces the payer-to-payer data exchange provisions. As a matter of enforcement discretion, CMS does not expect to take action to enforce compliance with these specific provisions until we are able to address certain implementation challenges.
329 The Food and Drug Administration (FDA or we) is classifying the ingested, transient, space occupying device for weight management and/or weight loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the ingested, transient, space occupying device for weight management and/or weight loss's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
330 The Food and Drug Administration (FDA, Agency, or we) is classifying the negative pressure wound therapy device for reduction of wound complications into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the negative pressure wound therapy device for reduction of wound complications' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
331 The Food and Drug Administration (FDA, the Agency, or we) is classifying the transcutaneous electrical nerve stimulator for attention deficit hyperactivity disorder (ADHD) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the transcutaneous electrical nerve stimulator for ADHD's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
332 As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ("Tobacco Products; Required Warnings for Cigarette Packages and Advertisements"), which published on March 18, 2020. The new effective date is January 9, 2023.
333 The Food and Drug Administration (FDA or Agency) is publishing an order setting forth the final determination of a petition requesting exemption from premarket notification (510(k)) requirements for the generic device type, powered patient transport, all other powered patient transport (product code ILK), classified as class II devices. These devices are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs. These devices do not include motorized three-wheeled vehicles or wheelchairs, and are distinct from the device type, powered patient transport, powered patient stairway chair lifts, which is classified separately within the same regulation (product code PCD). FDA is publishing this order in accordance with procedures established in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
334 The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to establish a program for the testing of food in certain circumstances by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Establishing this program will help FDA improve the safety of the U.S. food supply and protect U.S. consumers by helping ensure that certain food testing of importance to public health is conducted subject to appropriate oversight and in accordance with appropriate model standards to produce reliable and valid test results.
335 The Food and Drug Administration (FDA or we) is classifying the isocapnic ventilation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the isocapnic ventilation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
336 The Food and Drug Administration (FDA or we) is classifying the esophageal tissue characterization system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the esophageal tissue characterization system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
337 The Food and Drug Administration (FDA or we) is classifying the trunk and limb electrical stimulator to treat headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the trunk and limb electrical stimulator to treat headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
338 The Food and Drug Administration (FDA or we) is classifying the conditioning tool for eating disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the conditioning tool for eating disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
339 The Food and Drug Administration (FDA or we) is classifying the intraoperative orthopedic strain sensor into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intraoperative orthopedic strain sensor's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
340 This document corrects typographical errors in the final rule that appeared in the August 13, 2021, Federal Register as well as additional typographical errors in a related correcting amendment that appeared in the October 20, 2021, Federal Register. The final rule was titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program''.
341 The Food and Drug Administration (FDA or we) is classifying the general laparoscopic power morcellation containment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the general laparoscopic power morcellation containment system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.
342 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III devices (product codes MZP and OBF), into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named "nucleic acid-based hepatitis C virus (HCV) ribonucleic acid tests." FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.
343 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is renaming and codifying these devices under the classification regulation named "hepatitis C virus (HCV) antibody tests." FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.
344 The Food and Drug Administration (FDA, Agency, or we) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) following the reclassification of multiple use blood lancets for multiple patient use from class I to class III.
345 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify three types of blood lancets used to puncture skin to obtain a drop of blood for diagnostic purposes from class I (general controls) exempt from premarket notification into class II (special controls) and subject to premarket notification, specifically, single use only blood lancets with an integral sharps injury prevention feature, single use only blood lancets without an integral sharps injury prevention feature, and multiple use blood lancets for single patient use only. FDA is designating special controls for these three types of blood lancets based on the determination that general controls only are not sufficient and there is sufficient information to establish special controls to provide a reasonable assurance of their safety and effectiveness. FDA is also reclassifying a fourth type of blood lancet, multiple use blood lancets for multiple patient use, from class I (general controls) exempt from premarket notification into class III (premarket approval). FDA is reclassifying these four types of blood lancets on its own initiative based on new information.
346 This interim final rule with comment period (IFC) freezes the payment to Opioid Treatment Programs for methadone in CY 2022 at the CY 2021 rate because it would not be appropriate to implement a decrease to the rate when substance use and overdoses have been exacerbated by the Coronavirus Disease 2019 (COVID-19) pandemic.
347 This final rule will delay for 6 months the January 1, 2022 effective date for amendatory instruction 10.a., which addresses the reporting by manufacturers of multiple best prices connected to a value based purchasing (VBP) arrangement, of the final rule entitled, "Medicaid Program; Establishing Minimum Standards in Medicaid State Drug Utilization Review (DUR) and Supporting Value-Based Purchasing (VBP) for Drugs Covered in Medicaid, Revising Medicaid Drug Rebate and Third Party Liability (TPL) Requirements", published in the December 31, 2020 Federal Register to July 1, 2022. This final rule will also delay for 9 months the April 1, 2022 effective date of inclusion (hereinafter referred to as the inclusion date) of the U.S. territories (American Samoa, Northern Mariana Islands, Guam, Puerto Rico, and the Virgin Islands) in the amended regulatory definitions of "States" and "United States" for purposes of the Medicaid Drug Rebate Program (MDRP), adopted in the interim final rule with comment period entitled, "Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States", published in the November 25, 2019 Federal Register to January 1, 2023. We requested public comment on the proposed delays of the applicable effective date and inclusion date and discuss the comments received in this final rule.
348 This major final rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; updates to certain Medicare provider enrollment policies; requirements for prepayment and post- payment medical review activities; requirement for electronic prescribing for controlled substances for a covered Part D drug under a prescription drug plan, or a Medicare Advantage Prescription Drug (MA- PD) plan; updates to the Medicare Ground Ambulance Data Collection System; changes to the Medicare Diabetes Prevention Program (MDPP) expanded model; and amendments to the physician self-referral law regulations.
349 This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2022 based on our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program, updates Hospital Price Transparency requirements, and updates and refines the design of the Radiation Oncology Model.
350 This final rule finalizes the provisions of the September 6, 2016 interim final rule that adjusts for inflation the maximum civil monetary penalty (CMP) amounts for all agencies within the Department of Health and Human Services (HHS) and updates certain agency-specific regulations. It also updates our required annual inflation-related increases to the CMP amounts in our regulations, under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015; adds references to new penalty authorities; and reflects technical changes to correct errors.
351 This final rule repeals the "Medicare Coverage of Innovative Technology (MCIT) and Definition of "Reasonable and Necessary" final rule, which was published on January 14, 2021, and was to be effective on December 15, 2021.
352 This final rule updates the home health and home infusion therapy services payment rates for calendar year (CY) 2022 in accordance with existing statutory and regulatory requirements. This rule also finalizes recalibration of the case-mix weights and updates the functional impairment levels, and comorbidity adjustment subgroups while maintaining the current low utilization payment adjustment (LUPA) thresholds for CY 2022. Additionally, this rule finalizes a policy to utilize the physical therapy LUPA add-on factor to establish the occupational therapy add-on factor for the LUPA add-on payment amounts and makes conforming regulations text changes to reflect that allowed practitioners are able to establish and review the plan of care. It also finalizes proposed changes to the Home Health Quality Reporting Program (QRP) including finalizing proposed measure removals and adoptions, public reporting, and modification of effective dates. It also finalizes proposed modifications to the effective date for the reporting of measures and certain standardized patient assessment data in the Inpatient Rehabilitation Facility (IRF) QRP and Long-Term Care Hospital (LTCH) QRP. In addition, this final rule codifies certain Medicare provider and supplier enrollment policies. It also makes permanent selected regulatory blanket waivers related to home health aide supervision that were issued to Medicare participating home health agencies during the COVID-19 public health emergency (PHE), and updates the home health conditions of participation regarding occupational therapists assessment completion to implement provisions of the Consolidated Appropriations Act, 2021 (CAA 2021). This final rule also finalizes proposals to expand the Home Health Value-Based Purchasing (HHVBP) Model and to end the original HHVBP Model one year early. Lastly, it establishes survey and enforcement requirements for hospice programs as set forth in the CAA 2021; and finalizes revisions to the infection control requirements for long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as "nursing homes") that will extend the mandatory COVID-19 reporting requirements beyond the current COVID-19 PHE until December 31, 2024.
353 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
354 This final rule updates the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2022. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rule updates requirements for the ESRD Quality Incentive Program (QIP), including a measure suppression policy for the duration of the coronavirus disease 2019 (COVID-19) public health emergency (PHE) as well as suppression of individual ESRD QIP measures for Payment Year (PY) 2022 under the measure suppression policy. This rule also finalizes that CMS will not score facilities or reduce payment to any facility under the ESRD QIP in PY 2022. Further, this rule finalizes changes to the ESRD Treatment Choices (ETC) Model, which is a mandatory payment model that is focused on encouraging greater use of home dialysis and kidney transplants, to reduce Medicare expenditures while preserving or enhancing the quality of care furnished to Medicare beneficiaries.
355 This interim final rule with comment period revises the requirements that most Medicare- and Medicaid-certified providers and suppliers must meet to participate in the Medicare and Medicaid programs. These changes are necessary to help protect the health and safety of residents, clients, patients, PACE participants, and staff, and reflect lessons learned to date as a result of the COVID-19 public health emergency. The revisions to the requirements establish COVID-19 vaccination requirements for staff at the included Medicare- and Medicaid-certified providers and suppliers.
356 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditional new animal drug applications (cNADAs) during January, February, and March 2021. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
357 This document corrects technical and typographical errors in the final rule that appeared in the August 13, 2021, issue of the Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2022 Rates; Quality Programs and Medicare Promoting Interoperability Program Requirements for Eligible Hospitals and Critical Access Hospitals; Changes to Medicaid Provider Enrollment; and Changes to the Medicare Shared Savings Program.''
358 The Food and Drug Administration (FDA or we) is responding to objections and a public hearing request that we received from Combe Inc., on the final rule entitled "Termination of Listing of Color Additives Exempt From Certification; Lead Acetate," which published on October 31, 2018. The final rule amended the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp. After reviewing the objections, we have concluded that the objections do not raise issues of material fact that justify a hearing. Therefore, the stay of the effectiveness for the repeal and delisting of the color additive regulation is now lifted, and we are amending the color additive regulations to no longer provide for the safe use of lead acetate in cosmetics intended for coloring hair on the scalp.
359 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical staplers for internal use (formerly regulated under the classification for "manual surgical instrument for general use" and assigned the product code GAG) from class I (general controls) into class II (special controls) and subject to premarket review. FDA is identifying the special controls for surgical staplers for internal use that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is issuing this reclassification on its own initiative based on new information. As part of this reclassification, FDA is also amending the existing classification for "manual surgical instrument for general use" to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.
360 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of silver nitrate as a color additive in professional-use only cosmetics to color eyebrows and eyelashes. This action is in response to a color additive petition (CAP) filed by GW Cosmetics GmbH.
361 The Food and Drug Administration (FDA, the Agency, us, or we) is issuing a final rule that sets forth requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule will help ensure that PMTAs contain sufficient information for FDA to determine whether a marketing granted order should be issued for a new tobacco product. The rule codifies the general procedures FDA will follow when evaluating PMTAs and creates postmarket reporting requirements for applicants that receive marketing granted orders. The rule also requires tobacco product manufacturers to keep records establishing that their tobacco products are legally marketed, such as documents showing that a tobacco product is not required to undergo premarket review or has received premarket authorization.
362 The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This final rule establishes procedures and criteria related to requests for De Novo classification ("De Novo request") and provides a pathway to obtain marketing authorization as a class I or class II device and for certain combination products. These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation. They are also intended to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval. The final rule implements the De Novo classification process under the FD&C Act, as enacted by the Food and Drug Administration Modernization Act of 1997 (FDAMA) and modified by the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act).
363 The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to provide additional information on the content and format of reports intended to demonstrate the substantial equivalence of a tobacco product (SE Reports). The final rule also establishes the general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications with the applicant and the confidentiality of data in an SE Report. The final rule will provide applicants with more certainty and clarity related to preparing and submitting SE Reports.
364 This document corrects technical errors that appeared in the final rule published in the Federal Register on August 4, 2021 entitled "Medicare Program; FY 2022 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2021 (FY 2022)".
365 The Food and Drug Administration (FDA, the Agency, we) is issuing a final rule that establishes procedures by which we may establish, amend, or revoke tolerances for residues of new animal drugs in any edible portion of any animal imported into the United States (import tolerances). These import tolerances provide a basis for the legal marketing of such animal-derived food.
366 As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ("Tobacco Products; Required Warnings for Cigarette Packages and Advertisements"), which published on March 18, 2020. The new effective date is October 11, 2022.
367 This document announces the continuation of, effectiveness of, and the extension of the timeline for publication of a final rule. We are issuing this document in accordance with the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in the Act if the Secretary publishes a notice of continuation explaining why we did not comply with the regular publication timeline.
368 The Food and Drug Administration (FDA or we) is amending the biologics regulation to improve clarity and revise an incorrect citation. This action is being taken to ensure the accuracy and clarity of the biologics regulation.
369 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of an aqueous extract of butterfly pea flower (Clitoria ternatea) as a color additive in various food categories at levels consistent with good manufacturing practice. We are taking this action in response to a color additive petition (CAP) submitted by Exponent, Inc., on behalf of Sensient Colors, LLC (Sensient).
370 This final rule revises the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2022 and to implement certain recent legislation. The final rule also updates the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long- term care hospitals (LTCHs) for FY 2022. It also finalizes a May 10, 2021 interim final rule with comment period regarding rural reclassification through the Medicare Geographic Classification Review Board (MGCRB). The final rule also implements changes and updates for the Medicare Promoting Interoperability, Hospital Value-Based Purchasing, Hospital Readmissions Reduction, Hospital Inpatient Quality Reporting, Hospital-Acquired Condition Reduction, the PPS-Exempt Cancer Hospital Reporting, and the Long-Term Care Hospital Quality Reporting programs. It also finalizes provisions that alleviate a longstanding problem related to claiming Medicare bad debt and provide a participation opportunity for eligible accountable care organizations (ACOs).
371 This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2022. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2022. This final rule also includes updates for the IRF Quality Reporting Program (QRP). In addition, we are finalizing a Medicare provision adopted in an interim final rule with comment period (IFC) issued on May 11, 2018 related to fee schedule adjustments for wheelchair accessories (including seating systems) and seat and back cushions furnished in connection with group 3 or higher complex rehabilitative power wheelchairs as well as changes to the regulations related to the Further Consolidated Appropriations Act, 2020 governing payment for these and other items.
372 This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2022. In addition, the final rule includes a forecast error adjustment for FY 2022, updates the diagnosis code mappings used under the Patient Driven Payment Model (PDPM), rebases and revises the SNF market basket, implements a recently-enacted SNF consolidated billing exclusion along with the required proportional reduction in the SNF PPS base rates, and includes a discussion of a PDPM parity adjustment. In addition, the final rule includes updates for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program, including a policy to suppress the use of the SNF readmission measure for scoring and payment adjustment purposes in the FY 2022 SNF VBP Program because we have determined that circumstances caused by the public health emergency for COVID-19 have significantly affected the validity and reliability of the measure and resulting performance scores. We are also finalizing a technical correction to the physical environment requirements that Long-Term Care facilities must meet in order to participate in the Medicare and Medicaid programs.
373 This final rule updates the hospice wage index, payment rates, and aggregate cap amount for Fiscal Year 2022. This rule makes changes to the labor shares of the hospice payment rates and finalizes clarifying regulations text changes to the election statement addendum that was implemented on October 1, 2020. In addition, this rule makes permanent selected regulatory blanket waivers that were issued to Medicare-participating hospice agencies during the COVID-19 public health emergency (PHE) and updates the hospice conditions of participation. This rule updates the Hospice Quality Reporting Program and finalizes changes beginning with the January 2022 public reporting for the Home Health Quality Reporting Program to address exceptions related to the COVID-19 PHE.
374 This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. This rule also updates and clarifies the IPF teaching policy with respect to IPF hospital closures and displaced residents and finalizes a technical change to one of the 2016-based IPF market basket price proxies. In addition, this final rule finalizes proposals on quality measures and reporting requirements under the Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program. We note that this final rule does not finalize two proposals to remove quality measures. The changes finalized in this rule for the IPFQR Program are effective for IPF discharges occurring during the Fiscal Year (FY) beginning October 1, 2021 through September 30, 2022 (FY 2022).
375 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its medical product "intended use" regulations. This final rule amends FDA's regulations describing the types of evidence relevant to determining whether a product is intended for use as a drug or device under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Public Health Service Act (PHS Act), and FDA's implementing regulations, including whether a medical product that is approved, cleared, granted marketing authorization, or exempted from premarket notification is intended for a new use. This action also withdraws and replaces the portions of a final rule issued on January 9, 2017, that never became effective.
376 This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment.
377 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of selenomethionine hydroxy analogue as a source of selenium in feed for beef and dairy cattle. This action is in response to a food additive petition filed by Adisseo France S.A.S.
378 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a precursor of creatine in poultry feeds. This action is in response to a food additive petition filed by Alzchem Trostberg GmbH.
379 As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ("Tobacco Products; Required Warnings for Cigarette Packages and Advertisements"), which published on March 18, 2020. The new effective date is July 13, 2022.
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381 This document finalizes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2022 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Health Insurance Exchanges, and incorporates the effects on such payment amounts the American Rescue Plan Act of 2021 (ARP).
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383 This document corrects technical errors that appeared in the final rule published in the May 3, 2021, Federal Register, titled "Medicare Program: Comprehensive Care for Joint Replacement Model Three Year Extension and Changes to Episode Definition and Pricing; Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency."
384 The Food and Drug Administration (FDA or we) is issuing a final rule to revoke the standards of identity for lowfat yogurt and nonfat yogurt and amend the standard of identity for yogurt in numerous respects. This action is in response, in part, to a citizen petition submitted by the National Yogurt Association (NYA). The final rule modernizes the yogurt standard to allow for technological advances while preserving the basic nature and essential characteristics of yogurt and promoting honesty and fair dealing in the interest of consumers.
385 This document corrects technical and typographical errors in the final rule that appeared in the January 19, 2021 Federal Register titled "Medicare and Medicaid Programs; Contract Year 2022 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, Medicaid Program, Medicare Cost Plan Program, and Programs of All Inclusive Care for the Elderly." The effective date of the final rule was March 22, 2021.
386 This final rule delays the effective date of the final rule titled, "Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of 'Reasonable and Necessary' " published in the January 14, 2021 Federal Register.
387 This interim final rule with comment period (IFC) revises the infection control requirements that long-term care (LTC) facilities (Medicaid nursing facilities and Medicare skilled nursing facilities, also collectively known as "nursing homes") and intermediate care facilities for individuals with intellectual disabilities (ICFs-IID) must meet to participate in the Medicare and Medicaid programs. This IFC aims to reduce the spread of SARS-CoV-2 infections, the virus that causes COVID-19, by requiring education about COVID-19 vaccines for LTC facility residents, ICF-IID clients, and staff serving both populations, and by requiring that such vaccines, when available, be offered to all residents, clients, and staff. It also requires LTC facilities to report COVID-19 vaccination status of residents and staff to the Centers for Disease Control and Prevention (CDC). These requirements are necessary to help protect the health and safety of ICF-IID clients and LTC facility residents. In addition, the rule solicits public comments on the potential application of these or other requirements to other congregate living settings over which CMS has regulatory or other oversight authority.
388 This interim final rule with comment period (IFC) amends our current regulations to allow hospitals with a rural redesignation under the Social Security Act (the Act) to reclassify through the Medicare Geographic Classification Review Board (MGCRB) using the rural reclassified area as the geographic area in which the hospital is located. These regulatory changes align our policy with the decision in Bates County Memorial Hospital v. Azar, effective with reclassifications beginning with fiscal year (FY) 2023. We would also apply the policy in this IFC when deciding timely appeals before the Administrator of applications for reclassifications beginning with FY 2022 that were denied by the MGCRB due to the current policy, which does not permit hospitals with rural redesignations to use the rural area's wage data for purposes of reclassifying under the MGCRB.
389 This final rule extends the length of the Comprehensive Care for Joint Replacement (CJR) model through December 31, 2024 by adding an additional 3 performance years (PYs). PY 6 will begin on October 1, 2021 and end on December 31, 2022; PY 7 will begin on January 1, 2023 and end on December 31, 2023; and PY 8 will begin on January 1, 2024 and end on December 31, 2024. In addition, this final rule revises certain aspects of the CJR model including the episode of care definition, the target price calculation, the reconciliation process, the beneficiary notice requirements, and the appeals process. In addition, for PY 6 through 8, this final rule eliminates the 50 percent cap on gainsharing payments, distribution payments, and downstream distribution payments for certain recipients. This final rule extends the additional flexibilities provided to participant hospitals related to certain Medicare program rules consistent with the revised episode of care definition.
390 This document announces the continuation of effectiveness of a Medicare interim final rule and the extension of the timeline for publication of the final rule. Section 1871(a)(3)(B) of the Social Security Act (the Act) specifies that a Medicare final rule must be published no later than 3 years after the publication date of the proposed or interim final rule, except under exceptional circumstances. In accordance with sections 1871(a)(3)(B) and 1871(a)(3)(C) of the Act, we are providing a notification of continuation for a Medicare interim final rule, announcing the different timeline on which we intend to publish the final rule, and explaining why we were unable to publish the final rule on the regular, required 3-year timeline.
391 The Food and Drug Administration (FDA, Agency, or we) is amending certain classification regulations to reflect changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) made by the 21st Century Cures Act (the Cures Act). The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act.
392 The Food and Drug Administration (FDA, the Agency, or we) is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the Drug Registration Number for human drugs and for animal drugs. The present revisions are necessary to correct editorial errors and to ensure that the codified cites the correct section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The electronic import entries regulation provides that the Drug Registration Number, which must be submitted at the time of entry in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), is the unique facility identifier specified in the FD&C Act. This rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
393 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2020. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
394 The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete office with updated information. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
395 On August 31, 2016, the Food and Drug Administration (FDA or Agency) published an amended final rule that listed inaccurate cross- references to FDA's drug establishment registration and drug listing regulations. This document corrects the inaccurate cross-references used in the final regulations.
396 The Department of Health and Human Services (HHS or Department) is postponing, pending judicial review, the effective date of a final rule entitled "Securing Updated and Necessary Statutory Evaluations Timely" (SUNSET final rule) and published in the Federal Register of January 19, 2021. This document also corrects certain errors in the SUNSET final rule.
397 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2020. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
398 This document corrects technical errors in the final rule that appeared in the December 28, 2020, Federal Register entitled, "Medicare Program; CY 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-in Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions from the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19" (hereinafter referred to as the CY 2021 PFS final rule).
399 Consistent with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, titled "Regulatory Freeze Pending Review," this document delays the effective date of the final rule titled, "Medicare Program; Medicare Coverage of Innovative Technology (MCIT) and Definition of 'Reasonable and Necessary' " published in the Federal Register on January 14, 2021, for 60 days. We are providing a 30-day public comment period to allow interested parties to provide comments about issues of fact, law, and policy raised by the rule and this information could be considered by the agency in determining whether further actions are appropriate, which could include whether to revise or rescind.
400 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2020. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.
401 This document corrects technical and typographical errors in the final rule with comment period and interim final rule with comment period published in the Federal Register on December 29, 2020, titled "Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; Physician-owned Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity To Apply for Available Slots; Radiation Oncology Model; and Reporting Requirements for Hospitals and Critical Access Hospitals (CAHs) to Report COVID-19 Therapeutic Inventory and Usage and to Report Acute Respiratory Illness During the Public Health Emergency (PHE) for Coronavirus Disease 2019 (COVID-19)".
402 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of seven new animal drug applications (NADAs) for lack of compliance with the reporting requirements in an FDA regulation.
403 The Food and Drug Administration (FDA) is withdrawing approval of seven new animal drug applications (NADAs) from multiple holders of these applications. The basis for the withdrawals is that the holders of these applications have repeatedly failed to file required annual reports for the applications.
404 This document corrects a typographical error in the final rule that appeared in the December 28, 2020 Federal Register (hereinafter referred to as the CY 2021 PFS final rule). The effective date was January 1, 2021.
405 In accordance with the memorandum of January 20, 2021 from the Assistant to the President and the Chief of Staff, entitled "Regulatory Review," this action temporarily delays for 60 days the effective date of the December 31, 2020 final rule entitled, "Medicare Program; Secure Electronic Prior Authorization For Medicare Part D", which published on December 31, 2020.
406 In accordance with the memorandum of January 20, 2021, from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review," this action temporarily delays for 60 days the effective date of part of the final rule entitled, "Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations; Final rule" published in the Federal Register on December 2, 2020. We are also providing an additional 30-day public comment period.
407 This document corrects technical errors in the final rule that appeared in the December 28, 2020, Federal Register under the same as title above. Hereinafter, the December 28 rule is referred to as the CY 2021 PFS final rule.
408 The Regulatory Flexibility Act (RFA) requires agencies to publish plans to conduct periodic reviews of certain of their regulations. Multiple Executive Orders also require agencies to submit plans for periodic reviews of certain regulations. To further comply with the RFA and Executive Orders, and to ensure the Department's regulations have appropriate impacts, the U.S. Department of Health and Human Services (HHS or the Department) issues this final rule amending its regulations to set expiration dates for the Department's regulations (subject to certain exceptions), unless the Department periodically assesses the regulations to determine if they are subject to the RFA, and if they are, performs a review that satisfies the criteria in the RFA.
409 This final rule will revise regulations for the Medicare Advantage (Part C) program, Medicare Prescription Drug Benefit (Part D) program, Medicaid program, Medicare Cost Plan program, and Programs of All-Inclusive Care for the Elderly (PACE) to implement certain sections of the Bipartisan Budget Act of 2018 and the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment--(SUPPORT) for Patients and Communities Act (hereinafter referred to as the SUPPORT Act), enhance the Part C and D programs and the PACE program, codify several existing CMS policies, make required statutory changes, implement other technical changes, and make routine updates. As stated in the final rule that appeared in the Federal Register on June 2, 2020, CMS is fulfilling its intention to address the remaining proposals from the February 2020 proposed rule here. Although the provisions adopted in this second final rule will be in effect during 2021, most provisions will apply to coverage beginning January 1, 2022. Notwithstanding the foregoing, for proposals from the February 2020 proposed rule that would codify statutory requirements that were already in effect prior to this rule's appearance in the Federal Register, CMS reminds organizations, plan sponsors, and other readers that the statutory provisions apply and will continue to be enforced. Similarly, for the proposals from the February 2020 proposed rule that would implement the statutory requirements in sections 2007 and 2008 of the SUPPORT Act, CMS intends to implement these statutory provisions consistent with their effective provisions.
410 As required by an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ("Tobacco Products; Required Warnings for Cigarette Packages and Advertisements"), which published on March 18, 2020. The new effective date is January 14, 2022.
411 This final rule establishes a Medicare coverage pathway to provide Medicare beneficiaries nationwide with faster access to new, innovative medical devices designated as breakthrough by the Food and Drug Administration (FDA). The Medicare Coverage of Innovative Technology (MCIT) pathway will result in 4 years of national Medicare coverage starting on the date of FDA market authorization or a manufacturer chosen date within 2 years thereafter. This rule also implements regulatory standards to be used in making reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act (the Act) for items and services that are furnished under Part A and Part B.
412 The Food and Drug Administration (FDA or we) is establishing January 1, 2024, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2021, and on or before December 31, 2022. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of labeling changes.
413 This final rule names a new transaction standard for the Medicare Prescription Drug Benefit program's (Part D) e-prescribing program as required by the "Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT Act." Under the SUPPORT Act, the Secretary is required to adopt standards for the Part D e-prescribing program to ensure secure electronic prior authorization request and response transmissions. In this final rule, we amend the Part D e- prescribing regulations to require Part D plan sponsors' support of version 2017071 of the National Council for Prescription Drug Programs (NCPDP) SCRIPT standard for use in certain electronic Prior Authorization (ePA) transactions with prescribers regarding Part D- covered drugs to Part D-eligible individuals.
414 This final rule will advance CMS' efforts to support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid. To ensure that the regulatory framework is sufficient to support such arrangements and to promote transparency, flexibility, and innovation in drug pricing without undue administrative burden, we are finalizing new regulatory policies and clarifying certain already established policies to assist manufacturers and states in participating in VBPs in a manner that is consistent with the law and maintains the integrity of the Medicaid Drug Rebate Program (MDRP). This final rule also revises regulations regarding: Authorized generic sales when manufacturers calculate average manufacturer price (AMP) for the brand name drug; pharmacy benefit managers (PBM) accumulator programs and their impact on AMP and best price when manufacturer- sponsored assistance is not passed through to the patient; state and manufacturer reporting requirements to the MDRP; new Medicaid Drug Utilization Review (DUR) provisions designed to reduce opioid related fraud, misuse and abuse; the definitions of CMS-authorized supplemental rebate agreement, line extension, new formulation, oral solid dosage form, single source drug, multiple source drug, innovator multiple source drug for purposes of the MDRP; payments for prescription drugs under the Medicaid program; and coordination of benefits (COB) and third party liability (TPL) rules related to the special treatment of certain types of care and payment in Medicaid and Children's Health Insurance Program (CHIP).
415 This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2021 based on our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this final rule with comment period establishes and updates the Overall Hospital Quality Star Rating beginning with the CY 2021; removes certain restrictions on the expansion of physician-owned hospitals that qualify as "high Medicaid facilities," and clarifies that certain beds are counted toward a hospital's baseline number of operating rooms, procedure rooms, and beds; adds two new service categories to the Hospital Outpatient Department (OPD) Prior Authorization Process; provides notice of the closure of two teaching hospitals and the opportunity to apply for available slots for purposes of indirect medical education (IME) and direct graduate medical education (DGME) payments; and revises the Clinical Laboratory Date of Service (DOS) policy. This interim final rule with comment period modifies the Radiation Oncology Model (RO Model) Model performance period for CY 2021, and establishes new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) for tracking of COVID-19 therapeutic inventory and usage and for tracking of the incidence and impact of Acute Respiratory Illness (including, but not limited to, Seasonal Influenza Virus, Influenza-like Illness, and Severe Acute Respiratory Infection) during the ongoing COVID-19 public health emergency (PHE).
416 This major final rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program requirements; Medicaid Promoting Interoperability Program requirements for Eligible Professionals; updates to the Quality Payment Program; Medicare coverage of opioid use disorder services furnished by opioid treatment programs; Medicare enrollment of Opioid Treatment Programs; payment for office/outpatient evaluation and management services; Requirement for Electronic Prescribing for Controlled Substances for a Covered Part D drug under a prescription drug plan or an MA-PD plan and Medicare Diabetes Prevention Program (MDPP) expanded model Emergency Policy. This final rule also finalizes certain provisions of the interim final rules with comment period that CMS issued on March 31, 2020, May 8, 2020\\,\\ and September 2, 2020 in response to the Public Health Emergency (PHE) for the Coronavirus Disease 2019 (COVID-19). This rule also establishes coding and payment for virtual check-in services and for personal protective equipment (PPE) on an interim final basis.
417 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "The Use of an Alternate Name for Potassium Chloride in Food Labeling." This guidance explains our intent to exercise enforcement discretion for the declaration of the name "potassium salt," as an alternative to "potassium chloride," in the ingredient statement on the labels of foods that contain potassium chloride as an ingredient.
418 The Department of Health and Human Services is correcting a final rule that appeared in the Federal Register on November 16, 2020. This document had incorrectly designated footnotes and typographical errors.
419 This advisory is to update the submission date listed in the previous Federal Register document published on September 17, 2020, titled "Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians--Request for Current Billing Information for Qualifying APM Participants" that provides information to certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This update allows these clinicians to provide information to CMS regarding their billing information by December 13, 2020 in order to receive this payment.
420 This document corrects technical and typographical errors in the final rule that appeared in the September 18, 2020 issue of the Federal Register titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Final Policy Changes and Fiscal Year 2021 Rates; Quality Reporting and Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals".
421 This document corrects technical and typographical errors that appeared in the final rule published in the September 29, 2020 Federal Register entitled "Medicare Program; Specialty Care Models To Improve Quality of Care and Reduce Expenditures," which established the Radiation Oncology Model and the End-Stage Renal Disease Treatment Choices Model.
422 This final rule addresses any undue regulatory impact and burden of the physician self-referral law. This final rule is being issued in conjunction with the Centers for Medicare & Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint to Coordinated Care. This final rule establishes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. It also establishes a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; establishes a new exception for donations of cybersecurity technology and related services; and amends the existing exception for electronic health records (EHR) items and services. This final rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.
423 This final rule revises the Organ Procurement Organizations (OPOs) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures and increasing competition for open donation service areas (DSAs).
424 This final rule adopts certain changes to the risk adjustment data validation error estimation methodology beginning with the 2019 benefit year for states where the Department of Health and Human Services (HHS) operates the risk adjustment program. This rule is finalizing changes to the HHS-RADV error estimation methodology, which is used to calculate adjusted risk scores and risk adjustment transfers, beginning with the 2019 benefit year of HHS-RADV. This rule also finalizes a change to the benefit year to which HHS-RADV adjustments to risk scores and risk adjustment transfers would be applied beginning with the 2020 benefit year of HHS-RADV. These policies seek to further the integrity of HHS-RADV, address stakeholder feedback, promote fairness, and improve the predictability of HHS-RADV adjustments.
425 This interim final rule with comment period (IFC) implements the Most Favored Nation (MFN) Model, a new Medicare payment model under section 1115A of the Social Security Act (the Act). The MFN Model will test whether more closely aligning payment for Medicare Part B drugs and biologicals (hereafter, referred to as "drugs") with international prices and removing incentives to use higher-cost drugs can control unsustainable growth in Medicare Part B spending without adversely affecting quality of care for beneficiaries.
426 The U.S Department of Health and Human Services (HHS) is amending its regulations to make miscellaneous corrections, including correcting references to other regulations, misspellings and other typographical errors. This document is necessary to inform the public of these non-substantive changes to HHS's regulations.
427 This final rule advances CMS' efforts to streamline the Medicaid and Children's Health Insurance Program (CHIP) managed care regulatory framework and reflects a broader strategy to relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and innovation in the delivery of care. These revisions of the Medicaid and CHIP managed care regulations are intended to ensure that the regulatory framework is efficient and feasible for states to implement in a cost-effective manner and ensure that states can implement and operate Medicaid and CHIP managed care programs without undue administrative burdens.
428 This final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2021. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this rule updates requirements for the ESRD Quality Incentive Program (QIP).
429 This interim final rule with request for comments (IFC) discusses CMS's implementation of section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for Coronavirus Disease 2019 (COVID-19) vaccine and its administration. This IFC implements requirements in the CARES Act that providers of COVID-19 diagnostic tests make public their cash prices for those tests and establishes an enforcement scheme to enforce those requirements. This rule also establishes an add-on payment for cases involving the use of new COVID- 19 treatments under the Medicare Inpatient Prospective Payment System (IPPS). This IFC provides for separate payment for new COVID-19 treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for COVID-19 when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service. This rule also interprets and implements the requirement to maintain Medicaid beneficiary enrollment in order to receive the temporary increase in Federal funding in the Families First Coronavirus Response Act (FFCRA). This IFC modifies policies of the Comprehensive Care for Joint Replacement (CJR) model and adds technical changes to accommodate these policy changes. Specifically, we are extending Performance Year (PY) 5 by adding 6 months, creating an episode-based extreme and uncontrollable circumstances COVID-19 policy, providing two reconciliation periods for PY 5, and adding DRGs 521 and 522 for hip and knee procedures. This rule also amends regulations regarding coverage of preventive health services to implement section 3203 of the CARES Act, which shortens the timeframe within which non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage must begin to cover without cost sharing qualifying coronavirus preventive services, including recommended COVID-19 immunizations. This IFC also revises regulations to set forth flexibilities in the public notice requirements and post award public participation requirements for State Innovation Waivers under section 1332 of the Patient Protection and Affordable Care Act (PPACA) during the public health emergency for COVID-19.
430 This final rule updates the home health prospective payment system (HH PPS) payment rates and wage index for calendar year (CY) 2021. This final rule also implements the changes to the home health regulations regarding the use of telecommunications technology in providing services under the Medicare home health benefit as described in the "Medicare and Medicaid Programs, Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency" interim final rule with comment period (March 2020 COVID-19 IFC). In addition, this rule implements the permanent home infusion therapy services benefit and supplier enrollment requirements for CY 2021 and finalizes conforming regulations text changes excluding home infusion therapy services from coverage under the Medicare home health benefit. This rule also finalizes a policy to align the Home Health Value-Based Purchasing (HHVBP) Model data submission requirements with any exceptions or extensions granted for purposes of the Home Health Quality Reporting Program (HH QRP) during the COVID-19 PHE and also finalizes a policy for granting exceptions to the New Measures data reporting requirements during the COVID-19 PHE, as described in the "Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program" interim final rule with comment period (May 2020 COVID-19 IFC).
431 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels." The guidance describes FDA's views on the declaration of allulose on Nutrition Facts and Supplement Facts labels and the caloric content of allulose. The guidance also announces our intent to exercise enforcement discretion for the exclusion of allulose from the amount of Total Sugars and Added Sugars declared on the Nutrition Facts and Supplement Facts label and use of a general factor of 0.4 calories per gram (kcal/g) for allulose when calculating declarations on Nutrition and Supplement Facts labels.
432 This document corrects a typographical error in the payment advisory that appeared in the September 17, 2020 Federal Register titled "Medicare Program; Alternative Payment Model (APM) Incentive Payment Advisory for Clinicians--Request for Current Billing Information for Qualifying APM Participants".
433 This document corrects technical errors that appeared in the final rule published in the Federal Register on June 2, 2020 entitled "Medicare Program; Contract Year 2021 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program."
434 The Secretary of Health and Human Services (Secretary) is issuing a final rule to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada. Under this final rule, States and Indian Tribes, and in certain future circumstances pharmacists and wholesalers, may submit importation program proposals to the Food and Drug Administration (FDA, the Agency, or we) for review and authorization. An importation program may be cosponsored by a State, Indian Tribe, pharmacist, or wholesaler. The final rule contains all requirements necessary for a sponsor to demonstrate that their importation program will pose no additional risk to the public's health and safety. In addition, the final rule requires that the sponsor explain how they will ensure their program will result in a significant reduction in the cost of covered products to the American consumer.
435 This final rule implements two new mandatory Medicare payment models under section 1115A of the Social Security Act--the Radiation Oncology Model (RO Model) and the End-Stage Renal Disease (ESRD) Treatment Choices Model (ETC Model). The RO Model will promote quality and financial accountability for providers and suppliers of radiotherapy (RT). The RO Model will be a mandatory payment model and will test whether making prospective episode payments to hospital outpatient departments (HOPD) and freestanding radiation therapy centers for RT episodes of care preserves or enhances the quality of care furnished to Medicare beneficiaries while reducing Medicare program spending through enhanced financial accountability for RO Model participants. The ETC Model will be a mandatory payment model focused on encouraging greater use of home dialysis and kidney transplants, in order to preserve or enhance the quality of care furnished to Medicare beneficiaries while reducing Medicare expenditures. The ETC Model adjusts Medicare payments on certain dialysis and dialysis-related claims for participating ESRD facilities and clinicians caring for beneficiaries with ESRD--or Managing Clinicians--based on their rates of home dialysis transplant waitlisting, and living donor transplants. We believe that these two models will test ways to further our goals of reducing Medicare expenditures while preserving or enhancing the quality of care furnished to beneficiaries.
436 The Food and Drug Administration (FDA, the Agency, or we) is correcting a final rule that published in the Federal Register of July 29, 2020. That final rule requires electronic submission of certain postmarketing safety reports for approved new animal drugs and provides a procedure for requesting a temporary waiver of the electronic submission requirement. Table 2 of the final rule published with errors and this document corrects those errors. We are placing a corrected copy of the final rule in the docket.
437 We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2021 and to implement certain recent legislation. We are also making changes relating to Medicare graduate medical education (GME) for teaching hospitals. In addition, we are providing the market basket update that will apply to the rate- of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2021. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2021. In this FY 2021 IPPS/LTCH PPS final rule, we are finalizing changes to the new technology add-on payment pathway for certain antimicrobial products and other changes to new technology add-on payment policies, and the collection of market-based rate information on the Medicare cost report for cost reporting periods ending on or after January 1, 2021 and finalizing the adoption of a market-based MS- DRG relative weight methodology beginning in FY 2024. We are establishing new requirements or revising existing requirements for quality reporting by acute care hospitals and PPS-exempt cancer hospitals. We also established new requirements and revised existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. We are also establishing performance standards for the Hospital Value-Based Purchasing (VBP) Program, and updating policies for the Hospital Readmissions Reduction Program and the Hospital-Acquired Condition (HAC) Reduction Program.
438 This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Alternative Payment Model (APM) Incentive Payment that CMS does not have the current billing information needed to disburse the payment. This advisory provides information to these clinicians on how to update their billing information to receive this payment.
439 The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of August 13, 2020. The final rule establishes requirements concerning "gluten-free" labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients.
440 This document announces the continuation of, effectiveness of, and the extension of the timeline for publication of a final rule. We are issuing this document in accordance with section 1871(a)(3)(C) of the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in section 1871(a)(3)(B) of the Act if the Secretary publishes a notice of continuation explaining why we did not comply with the regular publication timeline.
441 This interim final rule with comment period (IFC) revises regulations to strengthen CMS' ability to enforce compliance with Medicare and Medicaid long-term care (LTC) facility requirements for reporting information related to coronavirus disease 2019 (COVID-19), establishes a new requirement for LTC facilities for COVID-19 testing of facility residents and staff, establishes new requirements in the hospital and critical access hospital (CAH) Conditions of Participation (CoPs) for tracking the incidence and impact of COVID-19 to assist public health officials in detecting outbreaks and saving lives, and establishes requirements for all CLIA laboratories to report COVID-19 test results to the Secretary of Health and Human Services (Secretary) in such form and manner, and at such timing and frequency, as the Secretary may prescribe during the Public Health Emergency (PHE).
442 In the August 6, 2015 issue of the Federal Register, we published a final rule that provided hospice quality reporting program updates, including finalizing the proposal to codify the Hospice Quality Reporting Program Submission Extension and Exemption Requirements. The effective date of the final rule was October 1, 2015. This correcting amendment corrects an omission identified in the August 6, 2015 final rule.
443 In the August 4, 2020 issue of the Federal Register, we published a final rule entitled "FY 2021 Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) and Special Requirements for Psychiatric Hospitals for Fiscal Year Beginning October 1, 2020 (FY 2021)". The August 4, 2020 final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System (IPPS) hospital or critical access hospital. In addition, we adopted more recent Office of Management and Budget (OMB) statistical area delineations, and applied a 2-year transition for all providers negatively impacted by wage index changes. This correction document corrects the statement of economic significance in the August 4, 2020 final rule.
444 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to remove the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The rule is being finalized because the existing test for Mycoplasma is overly restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the specific method to test for Mycoplasma provides flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. This action is part of FDA's implementation of Executive Orders under which FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
445 The Food and Drug Administration (FDA or Agency) is providing notice of a stay of the effectiveness of provisions for devices in use on specific individuals who have or would need to obtain a physician- directed transition plan as of the date of publication on March 6, 2020, of the final regulation banning electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA is publishing this notification in response to petitions for an administrative stay of action in accordance with regulatory requirements.
446 The Food and Drug Administration (FDA, the Agency, or we) is revising its regulations to reflect changes to the Agency's organizational structure, including the reorganization of the Office of Regulatory Affairs (ORA). The revisions update addresses and replace references to the district officials with references to division officials. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
447 The Food and Drug Administration (FDA) is amending the animal drug regulations to revise a current mailing address and to add an email address to the previously codified contact information for use by distributors of an animal feed containing a veterinary feed directive (VFD) drug or a combination VFD drug. This technical amendment is being made to improve the accuracy and completeness of the regulations.
448 This document finalizes the methodology and data sources necessary to determine federal payment amounts to be made for program year 2021 to states that elect to establish a Basic Health Program under the Patient Protection and Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.
449 The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements concerning "gluten-free" labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. These requirements f are needed to help ensure that individuals with celiac disease are not misled and receive truthful and accurate information with respect to fermented or hydrolyzed foods labeled as "gluten- free." Currently, FDA knows of no scientifically valid analytical method effective in detecting and quantifying with precision the gluten protein content in fermented or hydrolyzed foods in terms of equivalent amounts of intact gluten proteins. Thus, we plan to evaluate compliance of such fermented or hydrolyzed foods that bear a "gluten-free" claim based on records that are made and kept by the manufacturer of the food bearing the "gluten-free" claim and made available to us for inspection and copying. The records need to provide adequate assurance that the food or ingredients used in the food are "gluten-free" before fermentation or hydrolysis. Once we identify that a scientifically valid method has been developed that can accurately detect and quantify gluten in fermented or hydrolyzed foods or ingredients, it would no longer be necessary for the manufacturer of foods bearing the "gluten-free" claim to make and keep these records. In addition, because currently there is no scientifically valid analytical method effective in detecting and quantifying the gluten protein content in fermented or hydrolyzed foods the final rule requires the manufacturer of these kinds of foods bearing the "gluten- free" claim to document that it has adequately evaluated the potential for gluten cross-contact and, if identified, that the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. Likewise, the final rule requires manufacturers of foods that contain fermented or hydrolyzed ingredients and bear the "gluten-free" claim to make and keep records that demonstrate with adequate assurance that the fermented or hydrolyzed ingredients are "gluten-free" in compliance with the 2013 gluten-free food labeling final rule. Finally, this final rule states that we will evaluate compliance of distilled foods by verifying the absence of protein using scientifically valid analytical methods that can reliably detect the presence of protein or protein fragments in the distilled food.
450 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate.
451 This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2021. As required by statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2021. This final rule adopts more recent Office of Management and Budget statistical area delineations and applies a 5 percent cap on any wage index decreases compared to FY 2020 in a budget neutral manner. This final rule also amends the IRF coverage requirements to remove the post-admission physician evaluation requirement and codifies existing documentation instructions and guidance. In addition, this final rule amends the IRF coverage requirements to allow, beginning with the second week of admission to the IRF, a non-physician practitioner who is determined by the IRF to have specialized training and experience in inpatient rehabilitation to conduct 1 of the 3 required face-to-face visits with the patient per week, provided that such duties are within the non-physician practitioner's scope of practice under applicable state law.
452 This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2021. We are also making changes to the case-mix classification code mappings used under the SNF PPS and making two minor revisions in the regulation text. Additionally, we are adopting the recent revisions in Office of Management and Budget (OMB) statistical area delineations. This rule also updates the Skilled Nursing Facility Value-Based Purchasing (VBP) Program that affects Medicare payment to SNFs.
453 This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPF), which include psychiatric hospitals and excluded psychiatric units of an Inpatient Prospective Payment System hospital or critical access hospital. In addition, we are adopting more recent Office of Management and Budget statistical area delineations, and applying a 2-year transition for all providers negatively impacted by wage index changes. We are also removing the term licensed independent practitioner(s) from the regulations for psychiatric hospitals. On April 6, 2020, we published an interim final rule with comment period to implement this statutorily mandated change. This final rule responds to comments on the interim final rule regarding changes to the term licensed independent practitioner, finalizes the implementing regulation, and explains how the new procedure will be put into practice. These changes will be effective for IPF discharges beginning with the 2021 Fiscal Year (FY), which runs from October 1, 2020 through September 30, 2021 (FY 2021).
454 This final rule updates the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2021. This rule also revises the hospice wage index to reflect the current Office of Management and Budget area delineations, with a 5 percent cap on wage index decreases. In addition, this rule responds to comments on the modified election statement and the addendum examples that were posted on the Hospice Center web page to assist hospices in understanding the content requirements finalized in the FY 2020 Hospice Wage Index and Payment Rate Update final rule, effective for hospice elections beginning on and after October 1, 2020.
455 The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drugs. The final rule also provides a procedure for requesting a temporary waiver of the electronic submission requirement.
456 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2020. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
457 The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) at the sponsor's request because the product is no longer manufactured or marketed.
458 The Food and Drug Administration (FDA or the Agency) is publishing an order setting forth the Agency's final determination to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the list of class II devices. The exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the list of class II devices to reflect this final determination. FDA is publishing this order in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
459 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled "Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use." The guidance does not alter FDA's current thinking on the regulatory criteria of minimal manipulation and homologous use for human cells, tissues, and cellular and tissue-based product (HCT/P). The guidance announced in this notice supersedes the guidance of the same title dated November 2017 and corrected December 2017. The guidance revises section V of the November 2017 guidance to communicate that the Agency is extending the period of time during which FDA intends to exercise enforcement discretion regarding certain regulatory requirements for certain HCT/Ps; this time period will run through May 31, 2021, instead of November 30, 2020.
460 The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of vitamin D<INF>2</INF> mushroom powder as a nutrient supplement in specific food categories. This action is in response to a petition filed by Oakshire Naturals, LP.
461 The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff." This guidance revises the guidance by the same title issued November 5, 2018, and describes FDA's intention with respect to the enforcement of unique device identification (UDI) requirements for class I and unclassified devices, other than implantable, life-sustaining, or life- supporting (I/LS/LS) devices. In this revised guidance, FDA clarifies that, at this time, in light of the considerations described in the guidance, it does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before September 24, 2022. The guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
462 The Department of Health and Human Services ("the Department" or "HHS") is committed to ensuring the civil rights of all individuals who access or seek to access health programs or activities of covered entities under Section 1557 of the Patient Protection and Affordable Care Act ("ACA"). After considering public comments, in this final rule, the Department revises its Section 1557 regulations, Title IX regulations, and specific regulations of the Centers for Medicare & Medicaid Services ("CMS") as proposed, with minor and primarily technical corrections. This will better comply with the mandates of Congress, address legal concerns, relieve billions of dollars in undue regulatory burdens, further substantive compliance, reduce confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights statutes and regulations prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability.
463 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Temporary Policy During the COVID-19 Public Health Emergency Regarding the Qualified Exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption." Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices. The guidance communicates the Agency's intention to exercise enforcement discretion, in the manner described in the guidance, regarding sales to qualified end-users when determining eligibility for the qualified exemption from the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption, due to disruptions to supply chains, for the duration of the COVID-19 public health emergency.
464 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of silicon dioxide as an anticaking agent, grinding aid, antifoaming agent, or carrier in animal feed components (ingredients, intermediate premixes, premixes, supplements, or concentrates). This action is in response to a food additive petition filed by Evonik Corp.
465 This final rule will revise regulations for the Medicare Advantage (MA or Part C) program, Medicare Prescription Drug Benefit (Part D) program, and Medicare Cost Plan program to implement certain sections of the Bipartisan Budget Act of 2018 and the 21st Century Cures Act. In addition, it will enhance the Part C and D programs, codify several existing CMS policies, and implement other technical changes.
466 In accordance with an order issued by the U.S. District Court for the Eastern District of Texas, this action delays the effective date of the final rule ("Tobacco Products; Required Warnings for Cigarette Packages and Advertisements"), which published on March 18, 2020, from June 18, 2021, to October 16, 2021.
467 This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare, Medicaid, Basic Health Program, and Exchange beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the coronavirus disease 2019 (COVID-19). Recognizing the critical importance of expanding COVID-19 testing, we are amending several Medicare policies on an interim basis to cover FDA-authorized COVID-19 serology tests, to allow any healthcare professional authorized to do so under State law to order COVID-19 diagnostic laboratory tests (including serological and antibody tests), and to provide for new specimen collection fees for COVID-19 testing under the Physician Fee Schedule and Outpatient Prospective Payment System, during the public health emergency (PHE) for the COVID-19 pandemic. Recognizing the urgency of this situation, and understanding that some pre-existing CMS rules may inhibit innovative uses of technology and capacity that might otherwise be effective in the efforts to mitigate the impact of the pandemic on beneficiaries and the American public, we are amending several CMS policies and regulations in response to the COVID-19 PHE and recent legislation, as outlined in this IFC. These changes apply to physicians and other practitioners, hospice providers, federally qualified health centers, rural health clinics, hospitals, critical access hospitals (CAHs), community mental health centers (CMHCs), clinical laboratories, teaching hospitals, providers of the laboratory testing benefit in Medicaid, Opioid treatment programs, and quality reporting programs (QRPs) for inpatient rehabilitation facilities (IRFs), long-term care hospitals (LTCHs), skilled nursing facilities (SNFs), home health agencies (HHAs) and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers.
468 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled "Classification of Posterior Cervical Screw Systems: Small Entity Compliance Guide." This small entity compliance guide (SECG) is intended to help small entities comply with the final rule on the classification of posterior cervical screw systems.
469 This final rule is intended to move the health care ecosystem in the direction of interoperability, and to signal our commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve the quality and accessibility of information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected health care providers and payers.
470 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements During the COVID-19 Public Health Emergency." Given the public health emergency presented by COVID-19, this guidance document is being implemented without prior public comment because FDA has determined that prior public participation is not feasible or appropriate, but it remains subject to comment in accordance with the Agency's good guidance practices. The guidance communicates the Agency's intention not to enforce certain requirements for the onsite monitoring activities and certificates for the currently recognized accreditation bodies (ABs) and accredited third-party certification bodies (CBs) in the Accredited Third-Party Certification Program for human and animal food in certain circumstances. Because travel restrictions and advisories related to COVID-19 may impact the ability of recognized ABs and accredited CBs to conduct onsite activities, this guidance provides temporary flexibility so that recognized ABs can maintain the accreditations of their CBs, and so that already-issued certifications need not lapse, in certain circumstances.
471 This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the 2019 Novel Coronavirus (COVID-19). Recognizing the urgency of this situation, and understanding that some pre-existing Medicare payment rules may inhibit innovative uses of technology and capacity that might otherwise be effective in the efforts to mitigate the impact of the pandemic on Medicare beneficiaries and the American public, we are changing Medicare payment rules during the Public Health Emergency (PHE) for the COVID-19 pandemic so that physicians and other practitioners, home health and hospice providers, inpatient rehabilitation facilities, rural health clinics (RHCs), and federally qualified health centers (FQHCs) are allowed broad flexibilities to furnish services using remote communications technology to avoid exposure risks to health care providers, patients, and the community. We are also altering the applicable payment policies to provide specimen collection fees for independent laboratories collecting specimens from beneficiaries who are homebound or inpatients (not in a hospital) for COVID-19 testing. We are also expanding, on an interim basis, the list of destinations for which Medicare covers ambulance transports under Medicare Part B. In addition, we are making programmatic changes to the Medicare Diabetes Prevention Program (MDPP) and the Comprehensive Care for Joint Replacement (CJR) Model in light of the PHE, and program-specific requirements for the Quality Payment Program to avoid inadvertently creating incentives to place cost considerations above patient safety. This IFC will modify the calculation of the 2021 and 2022 Part C and D Star Ratings to address the expected disruption to data collection and measure scores posed by the COVID-19 pandemic and also to avoid inadvertently creating incentives to place cost considerations above patient safety. This rule also amends the Medicaid home health regulations to allow other licensed practitioners to order home health services, for the period of this PHE for the COVID-19 pandemic in accordance with state scope of practice laws. We are also modifying our under arrangements policy during the PHE for the COVID-19 pandemic so that hospitals are allowed broader flexibilities to furnish inpatient services, including routine services outside the hospital.
472 The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations. These revisions are necessary to reflect changes to the Agency's Center for Devices and Radiological Health's organizational structure, including the reorganization of its offices. The revisions replace references to the obsolete offices and positions with the current information, update the physical addresses for such offices, and correct inaccurate citations. In addition, as part of this effort we made other editorial non-substantive changes to correct other addresses, references, and citations, as appropriate. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
473 The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)) as indicated in the lists published on April 13, 2017, and July 11, 2017. FDA published a final amendment, final order in the Federal Register of December 30, 2019 ("Final Order") codifying the two Federal Register notices. The present revisions are necessary to correct editorial errors to ensure that the codified is consistent with the exemptions in the Federal Register notices. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
474 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
475 The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor's request because the products are no longer manufactured or marketed.
476 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency." The guidance communicates the Agency's intention not to enforce certain onsite audit requirements in three of our food safety regulations in certain circumstances related to the impact of the coronavirus if other supplier verification methods that are designed to provide sufficient assurance that hazards have been significantly minimized or prevented are used instead during the period of onsite audit delay.
477 The Food and Drug Administration (FDA, the Agency, or we) is revising chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the reorganization of the Office of Regulatory Affairs. The revisions replace references to the District Director with references to the Division Director and make other related changes. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
478 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide." This guidance is intended to help small businesses understand and comply with FDA's document entitled "Tobacco Products: Required Warnings for Cigarette Packages and Advertisements," which establishes new required cigarette health warnings for cigarette packages and advertisements.
479 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to establish new cigarette health warnings for cigarette packages and advertisements. The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics depicting the negative health consequences of smoking to accompany new textual warning label statements. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) of 1965 to require each cigarette package and advertisement to bear one of the new required warnings. The final rule specifies the 11 new textual warning label statements and accompanying color graphics. FDA is taking this action to promote greater public understanding of the negative health consequences of cigarette smoking.
480 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of supplemental chromium in horse feed. This action is in response to a food additive petition filed by Kemin Industries, Inc.
481 The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self- injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. This ban includes both new devices and devices already in distribution and use; however, this ban provides transition time for those individuals currently subject to ESDs for the identified intended use to transition off ESDs under the supervision of a physician.
482 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulation that defines "biological product" to incorporate changes made by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) and the Further Consolidated Appropriations Act, 2020 (FCA Act), and to provide its interpretation of the statutory term "protein." Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated.
483 In the November 12, 2019 issue of the Federal Register, we published a final rule with comment period that made changes to the conditions for therapeutic outpatient hospital or CAH services and supplies incident to a physician's or nonphysician practitioner's service. This correcting amendment corrects a technical error in the regulations resulting from an error in that final rule with comment period.
484 This document announces the continuation of prior authorization for 45 Healthcare Common Procedure Coding System (HCPCS) codes on the Required Prior Authorization List of DMEPOS Items that require prior authorization as a condition of payment, as well as the addition of six HCPCS codes to this list. Prior authorization for the additional codes will be implemented in two phases.
485 The Food and Drug Administration (FDA, the Agency, or we) is classifying the human immunodeficiency virus (HIV) drug resistance genotyping assay using next generation sequencing (NGS) technology into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the HIV drug resistance genotyping assay using NGS technology's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
486 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Food Labeling: Revision of the Nutrition and Supplement Facts Labeling--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with a final rule we issued in the Federal Register of May 27, 2016, entitled "Food Labeling: Revision of the Nutrition and Supplement Facts Labeling."
487 The Food and Drug Administration (FDA or we) is responding to the submission styled as an objection submitted by Earthjustice on behalf of Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, and the Natural Resources Defense Council, on the final rule that amended the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. The final rule also amended the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. After reviewing the submission, we have concluded that the submission we received is not an objection and consequently does not provide a basis for modifying the regulations.
488 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
489 The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and two abbreviated new animal drug applications (ANADAs) at the sponsors' request because the products are no longer manufactured or marketed.
490 The Food and Drug Administration (FDA or we) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological CADx software for lesions suspicious for cancer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
491 The Food and Drug Administration (FDA or we) is classifying the radiological computer aided triage and notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological computer aided triage and notification software's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
492 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type.
493 The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification (510(k)) requirements for powered wheeled stretchers (product code INK). These devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or supine position for prolonged periods because of skin ulcers or contractures (muscle contractions). This order exempts powered wheeled stretchers, class II devices, from 510(k) requirements, subject to certain conditions for exemption. This exemption from 510(k) requirements is immediately in effect for powered wheeled stretchers. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
494 This document corrects technical errors that appeared in the final rule with comment period that appeared in the November 12, 2019, issue of the Federal Register titled "Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children's Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity to Apply for Available Slots."
495 This document announces the continuation of, effectiveness of, and the extension of the timeline for publication of a final rule. We are issuing this document in accordance with the Social Security Act (the Act), which allows an interim final rule to remain in effect after the expiration of the timeline specified in the Act if the Secretary publishes a notice of continuation explaining why the regular timeline was not complied with.
496 This document corrects technical errors in the final rule that appeared in the November 15, 2019 Federal Register entitled, "Medicare Program; CY 2020 Revisions to Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self- Administered Esketamine Interim Final Rule" (referred to hereafter as the "CY 2020 PFS final rule").
497 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics." The final guidance provides questions and answers on topics related primarily to implementing two final rules, one entitled "Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments," and the other entitled "Food Labeling: Revision of the Nutrition and Supplement Facts Labels." The final guidance also discusses formatting issues for dual-column labeling, products that have limited space for nutrition labeling, and additional issues dealing with compliance.
498 The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.
499 This advisory is to alert certain clinicians who are Qualifying APM participants (QPs) and eligible to receive an Advanced Alternative Payment Model (APM) Incentive Payment that CMS does not have the current banking information needed to disburse the payment. This advisory provides information to these clinicians on how to update their banking information to receive this payment.
500 The Food and Drug Administration (FDA) is issuing a final order to reclassify the cranial electrotherapy stimulator (CES) device intended to treat anxiety and/or insomnia, a preamendments class III device, into class II (special controls) and subject to premarket notification. FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for CES devices intended to treat depression (product code JXK) and clarify the device identification of the CES device to include it as a prescription device.
501 The Food and Drug Administration (FDA or we) is responding to objections that it received from the Center for Food Safety on the final rule entitled "Listing of Color Additives Exempt from Certification; Soy Leghemoglobin," which published on August 1, 2019. The final rule amended the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. After reviewing the objections, FDA has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking the amendment to the regulations. We are also providing notice that the administrative stay of the effective date for this color additive regulation is now lifted.
502 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule repealing a regulation that requires an FDA- approved new drug application (NDA) or abbreviated new drug application (ANDA) for any drug product that is sterilized by irradiation (the irradiation regulation). Repealing the irradiation regulation will mean that over-the-counter (OTC) drug products that are generally recognized as safe and effective, are not misbranded, and comply with all applicable regulatory requirements can be marketed legally without an NDA or ANDA, even if they are sterilized by irradiation. FDA is taking this action because the irradiation regulation is out of date and unnecessary.
503 The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule amending requirements for medical device premarket submissions to remove paper and multiple copies and replace them with requirements for a single submission in electronic format. This action would reduce the number of copies in electronic format required, thus improving and making more efficient the FDA's premarket submission program for medical devices.
504 The Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment period, we amended the regulatory definitions of "States" and "United States" to include the U.S. territories (American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the Virgin Islands of the United States) beginning April 1, 2017. Subsequently, in the November 15, 2016 Federal Register, we published an interim final rule with comment period (IFC) to further delay the inclusion of the U.S. territories in the regulatory definitions of "States" and "United States" until beginning April 1, 2020. This IFC further delays the inclusion of the territories in the definitions of "States" and "United States" until beginning April 1, 2022.
505 This major final rule addresses: Changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program quality reporting requirements; Medicaid Promoting Interoperability Program requirements for eligible professionals; the establishment of an ambulance data collection system; updates to the Quality Payment Program; Medicare enrollment of Opioid Treatment Programs and enhancements to provider enrollment regulations concerning improper prescribing and patient harm; and amendments to Physician Self-Referral Law advisory opinion regulations. In addition, we are issuing an interim final rule with comment period (IFC) to establish coding and payment for evaluation and management, observation and the provision of self-administered Esketamine to facilitate beneficiary access to care for treatment-resistant depression as efficiently as possible.
506 This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year 2020 based on our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this final rule with comment period establishes a process and requirements for prior authorization for certain covered outpatient department services; revise the conditions for coverage of organ procurement organizations; and revise the regulations to allow grandfathered children's hospitals- within-hospitals to increase the number of beds without resulting in the loss of grandfathered status; and provides notice of the closure of two teaching hospitals and the opportunity to apply for available slots for purposes of indirect medical education (IME) and direct graduate medical education (DGME) payments.
507 This final rule with comment period updates the home health prospective payment system (HH PPS) payment rates and wage index for CY 2020; implements the Patient-Driven Groupings Model (PDGM), a revised case-mix adjustment methodology, for home health services beginning on or after January 1, 2020. This final rule with comment period also implements a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the Bipartisan Budget Act of 2018, hereinafter referred to the "BBA of 2018", and finalizes a 30-day payment amount for CY 2020. Additionally, this final rule with comment period: Modifies the payment regulations pertaining to the content of the home health plan of care; allows therapist assistants to furnish maintenance therapy; and changes the split percentage payment approach under the HH PPS. For the Home Health Value-Based Purchasing (HHVBP) model, we are finalizing provisions requiring the public reporting of the Total Performance Score (TPS) and the TPS Percentile Ranking from the Performance Year 5 (CY 2020) Annual TPS and Payment Adjustment Report for each home health agency in the nine Model states that qualified for a payment adjustment for CY 2020. This final rule with comment period also finalizes the following updates to the Home Health Quality Reporting Program (HH QRP): Removal of a measure; adoption of two new measures; modification of an existing measure; and a requirement for HHA's to report standardized patient assessment data beginning with the CY 2022 HH QRP. Additionally, we are finalizing our proposal to re-designate our current HH QRP regulations in a different section of our regulations and to codify other current policies in that new regulatory section with one substantive change as well as a few technical edits. We are not finalizing our proposal to remove question 10 from all of the HH Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys. Lastly, it sets forth routine updates to the home infusion therapy payment rates for CY 2020, payment provisions for home infusion therapy services for CY 2021 and subsequent years, and solicits comments on options to enhance future efforts to improve policies related to coverage of eligible drugs for home infusion therapy.
508 This final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2020. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). This rule also updates requirements for the ESRD Quality Incentive Program (QIP). In addition, this rule establishes a methodology for calculating fee schedule payment amounts for new Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) items and services, and a methodology for making adjustments to the fee schedule amounts established using supplier or commercial prices if such prices decrease within 5 years of establishing the initial fee schedule amounts. This rule also revises existing regulations related to the DMEPOS competitive bidding program. This rule also streamlines the requirements for ordering DMEPOS items, and develops a new list of DMEPOS items potentially subject to a face-to-face encounter, written orders prior to delivery and/or prior authorization requirements. Finally, this rule summarizes responses to requests for information on data collection resulting from the ESRD PPS technical expert panel, changing the basis for the ESRD PPS wage index, and new requirements for the competitive bidding of diabetic testing strips.
509 This document provides the methodology and data sources necessary to determine federal payment amounts for program years 2019 and 2020 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.
510 The Food and Drug Administration (FDA or we) is classifying the continuous glucose monitor data management system into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
511 The Food and Drug Administration (FDA or we) is classifying the self-fitting air-conduction hearing aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the self-fitting air-conduction hearing aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
512 The Food and Drug Administration (FDA or we) is issuing this final rule to revise the type size labeling requirements when front-of- pack (FOP) labeling is used to meet the calorie declaration requirements for articles of food sold from glass-front vending machines. We are taking this action to reduce the regulatory burden on industry, increase flexibility for the labeling of certain articles of food sold from glass-front vending machines, and ensure that consumers continue to have visible FOP calorie information for articles of food at the point of purchase.
513 The Food and Drug Administration (FDA or we) is classifying the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
514 The Food and Drug Administration (FDA or we) is classifying the internal therapeutic massager into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the internal therapeutic massager's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
515 This document corrects technical and typographical errors in the final rule that appeared in the August 16, 2019 issue of the Federal Register titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2020 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Requirements for Eligible Hospitals and Critical Access Hospitals."
516 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
517 This final rule reforms Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This final rule also increases the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care. Additionally, this rule updates fire safety standards for Medicare and Medicaid participating End-Stage Renal Disease (ESRD) facilities by adopting the 2012 edition of the Life Safety Code and the 2012 edition of the Health Care Facilities Code. Finally, this final rule updates the requirements that hospitals and Critical Access Hospitals (CAHs) must meet to participate in the Medicare and Medicaid programs. These requirements are intended to conform to current standards of practice and support improvements in quality of care, reduce barriers to care, and reduce some issues that may exacerbate workforce shortage concerns.
518 This final rule empowers patients to be active participants in the discharge planning process and complements efforts around interoperability that focus on the seamless exchange of patient information between health care settings by revising the discharge planning requirements that Hospitals (including Short-Term Acute-Care Hospitals, Long-Term Care Hospitals (LTCHs), Rehabilitation Hospitals, Psychiatric Hospitals, Children's Hospitals, and Cancer Hospitals), Critical Access Hospitals (CAHs), and Home Health Agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. This final rule also implements discharge planning requirements which will give patients and their families access to information that will help them to make informed decisions about their post-acute care, while addressing their goals of care and treatment preferences, which may ultimately reduce their chances of being re-hospitalized. It also updates one provision regarding patient rights in hospitals, intended to promote innovation and flexibility and to improve patient care.
519 The statute requires aggregate reductions to state Medicaid Disproportionate Share Hospital (DSH) allotments annually beginning with fiscal year (FY) 2020. This final rule delineates the methodology to implement the annual allotment reductions.
520 This final rule with comment period implements statutory provisions that require Medicare, Medicaid, and Children's Health Insurance Program (CHIP) providers and suppliers to disclose certain current and previous affiliations with other providers and suppliers. In addition, it provides the agency with additional authority to deny or revoke a provider's or supplier's Medicare enrollment in certain specified circumstances. The provisions we are finalizing in this rule are necessary to address various program integrity issues and vulnerabilities by enabling CMS to take action against unqualified and potentially fraudulent entities and individuals, which in turn could deter other parties from engaging in improper behavior.
521 We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2020 and to implement certain recent legislation. We also are making changes relating to Medicare graduate medical education (GME) for teaching hospitals and payments to critical access hospital (CAHs). In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2020. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2020. In this FY 2020 IPPS/LTCH PPS final rule, we are addressing wage index disparities impacting low wage index hospitals; providing for an alternative IPPS new technology add-on payment pathway for certain transformative new devices and qualified infectious disease products; and revising the calculation of the IPPS new technology add-on payment. In addition, we are revising and clarifying our policies related to the substantial clinical improvement criterion used for evaluating applications for the new technology add-on payment under the IPPS. We are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements and revising existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.
522 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2019. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. Technical amendments are also being made to improve the accuracy, consistency, and readability of the regulations.
523 The Food and Drug Administration (FDA) is withdrawing approval of two new animal drug applications (NADAs) at the sponsors' request because these products are no longer manufactured or marketed.
524 This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2020. As required by the statute, this final rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups (CMGs) and a description of the methodologies and data used in computing the prospective payment rates for FY 2020. This final rule rebases and revises the IRF market basket to reflect a 2016 base year rather than the current 2012 base year. Additionally, this final rule revises the CMGs and updates the CMG relative weights and average length of stay (LOS) values beginning with FY 2020, based on analysis of 2 years of data (FYs 2017 and 2018). Although we proposed to use a weighted motor score to assign patients to CMGs, we are finalizing based on public comments the use of an unweighted motor score to assign patients to CMGs beginning with FY 2020. Additionally, we are finalizing the removal of one item from the motor score. We are updating the IRF wage index to use the concurrent fiscal year inpatient prospective payment system (IPPS) wage index beginning with FY 2020. We are amending the regulations to clarify that the determination as to whether a physician qualifies as a rehabilitation physician (that is, a licensed physician with specialized training and experience in inpatient rehabilitation) is made by the IRF. For the IRF Quality Reporting Program (QRP), we are adopting two new measures, modifying an existing measure, and adopting new standardized patient assessment data elements. We are also making updates to reflect our migration to a new data submission system.
525 This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2020. We also are making minor revisions to the regulation text to reflect the revised assessment schedule under the Patient Driven Payment Model (PDPM). Additionally, we are revising the definition of group therapy under the SNF PPS, and are implementing a subregulatory process for updating the code lists (International Classification of Diseases, Tenth Version (ICD-10) codes) used under PDPM. In addition, the final rule updates requirements for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program.
526 This final rule updates the prospective payment rates, the outlier threshold, and the wage index for Medicare inpatient hospital services provided by Inpatient Psychiatric Facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an inpatient prospective payment system hospital or critical access hospital. Additionally, this final rule revises and rebases the IPF market basket to reflect a 2016 base year and removes the IPF Prospective Payment System (PPS) 1-year lag of the wage index data. Finally, this final rule implements updates to the Inpatient Psychiatric Facilities Quality Reporting Program. These changes will be effective for IPF discharges beginning during the fiscal year (FY) from October 1, 2019 through September 30, 2020 (FY 2020).
527 This final rule updates the hospice wage index, payment rates, and cap amount for fiscal year 2020. This rule also rebases the continuous home care, general inpatient care, and the inpatient respite care per diem payment rates in a budget-neutral manner to more accurately align Medicare payments with the costs of providing care. In addition, this rule modifies the election statement by requiring an addendum that includes information aimed at increasing coverage transparency for patient under a hospice election. Finally, this rule includes changes to the Hospice Quality Reporting Program.
528 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of soy leghemoglobin as a color additive in ground beef analogue products. We are taking this action in response to a color additive petition (CAP) submitted by Impossible Foods, Inc. (Impossible Foods or petitioner).
529 This final rule amends the requirements that Long-Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. Specifically, we are repealing the prohibition on the use of pre-dispute, binding arbitration agreements. We are also strengthening the transparency of arbitration agreements and arbitration in LTC facilities. This final rule supports residents' rights to make informed choices about important aspects of their health care.
530 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to revise the animal drug regulations for tolerances for residues of approved new animal drugs. This final rule is necessary to standardize, simplify, and clarify the determination standards of tolerances and provide definitions for key terms. This final rule will enhance understanding of tolerance determination and improve the overall readability of the relevant regulations.
531 The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of an immediately in effect guidance for industry entitled "Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency." This guidance describes FDA's policy concerning the conditions under which the Agency does not generally intend to take regulatory action against a licensed pharmacist in a State-licensed pharmacy or Federal facility or a licensed physician using the bulk drug substance oxitriptan (also known as 5-hydroxytryptophan or 5-HTP) to compound oral drug products for patients with tetrahydrobiopterin (BH4) deficiency. FDA developed this guidance in response to communications from pharmacists and caregivers regarding the use of oxitriptan to treat patients with BH4 deficiency following issuance of a final rule that placed oxitriptan on the list of substances that cannot be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
532 The Food and Drug Administration (FDA or Agency) is issuing a final rule to amend its regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH or the Center) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). This final rule codifies the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also finalizing regulations to provide new procedural requirements for requesting internal agency supervisory review within CDRH of other types of decisions made by CDRH not addressed in FDASIA and the Cures Act. This action is also part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve its public health mission and fulfill statutory obligations.
533 The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry describing the Agency's current thinking on how to determine the number of employees for purposes of the "small business" definition in the current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for human and animal food rules. The guidance will help industry subject to these rules determine the number of employees for purposes of the "small business" definition.
534 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "The Declaration of Added Sugars on Honey, Maple Syrup, Other Single- Ingredient Sugars and Syrups, and Certain Cranberry Products." This guidance provides clarification on the labeling requirements for single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups, which are not required to bear the words "Includes Xg Added Sugars," but must still include the percent Daily Value for added sugars on their labels. This guidance is also intended to advise food manufacturers of our intent to exercise enforcement discretion related to the use of a "[dagger]" symbol immediately following the percent Daily Value for added sugars on single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups; the "[dagger]" symbol would lead the consumer to a statement that is truthful and not misleading in a footnote at the bottom of the Nutrition Facts label. The guidance also advises food manufacturers of our intent to exercise enforcement discretion with respect to the use of a "[dagger]" symbol immediately after the added sugars percent Daily Value information that leads the consumer to a statement that is truthful and not misleading outside of the Nutrition Facts label on certain dried cranberry and cranberry beverage products that are made up of cranberry juice sweetened with added sugars and that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no added sugars. Further, this guidance advises of our intent to exercise enforcement discretion regarding compliance with Nutrition Facts label final rule and Serving Size final rule requirements until July 1, 2021, for the single-ingredient sugars and syrups as well as the cranberry products discussed in the guidance document.
535 The Food and Drug Administration (FDA) is announcing the availability of a final guidance for industry entitled "Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems, Guidance for Industry." Given the relatively new presence of electronic nicotine delivery systems (ENDS) on the U.S. market and FDA's final rule deeming these products to be subject to the tobacco product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA expects to receive premarket tobacco product application (PMTA) submissions from manufacturers of ENDS. This guidance is intended to assist applicants to prepare PMTAs for ENDS products.
536 This document corrects technical and typographical errors that appeared in the final rule published in the April 16, 2019 Federal Register titled "Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Programs of All-Inclusive Care for the Elderly (PACE), Medicaid Fee- For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021".
537 In accordance with court rulings in cases that challenge the federal fiscal year (FY) 2004, 2005, and 2006 outlier fixed-loss threshold (FLT) rulemakings, this document provides further explanation of certain methodological choices made in the FLT determinations for those years.
538 This final rule updates the requirements for the Programs of All-Inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The rule addresses application and waiver procedures, sanctions, enforcement actions and termination, administrative requirements, PACE services, participant rights, quality assessment and performance improvement, participant enrollment and disenrollment, payment, federal and state monitoring, data collection, record maintenance, and reporting. The changes will provide greater operational flexibility, remove redundancies and outdated information, and codify existing practice.
539 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Section 503A Bulks List Final Rule Questions and Answers--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule establishing the list of bulk drug substances that can be used in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
540 This final rule amends the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to support health and drug plans' negotiation for lower drug prices and reduce out-of-pocket costs for Part C and D enrollees. These amendments will improve the regulatory framework to facilitate development of Part C and Part D products that better meet the individual beneficiary's healthcare needs and reduce out-of-pocket spending for enrollees at the pharmacy and other sites of care.
541 The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of April 12, 2019. That document was published with the instruction to add a section to the incorrect subpart. This correction is being made to improve the accuracy of the final classification action.
542
543 This final rule revises the Federal Health Insurance Programs for the Aged and Disabled by amending regulations for the Medicare Parts A, B, C and D programs, as well as the Medicaid program, to require direct-to-consumer (DTC) television advertisements of prescription drugs and biological products for which payment is available through or under Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC or list price) of that drug or biological product. This rule is intended to improve the efficient administration of the Medicare and Medicaid programs by ensuring that beneficiaries are provided with relevant information about the costs of prescription drugs and biological products so they can make informed decisions that minimize their out-of-pocket (OOP) costs and expenditures borne by Medicare and Medicaid, both of which are significant problems.
544 This final rule revises the regulations setting forth the appeals process that Medicare beneficiaries, providers, and suppliers must follow in order to appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B or determinations for prescription drug coverage under Part D. These changes help to streamline the appeals process and reduce administrative burden on providers, suppliers, beneficiaries, and appeal adjudicators. These revisions, which include technical corrections, also help to ensure the regulations are clearly arranged and written to give stakeholders a better understanding of the appeals process.
545 This final rule removes the regulatory text that allows a state to make Medicaid payments to third parties on behalf of an individual provider for benefits such as health insurance, skills training, and other benefits customary for employees. We have concluded that this provision is neither explicitly nor implicitly authorized by the statute, which identifies the only permissible exceptions to the rule that only a provider may receive Medicaid payments. As we noted in our prior rulemaking, section 1902(a)(32) of the Social Security Act (the Act) provides for a number of exceptions to the direct payment requirement, but it does not authorize the agency to create new exceptions.
546 The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled "Compliance Policy for Combination Product Postmarketing Safety Reporting." This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.
547 This document announces the addition of 12 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment.
548 This document announces the addition of four Healthcare Common Procedure Coding System (HCPCS) codes to the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment.
549 The Food and Drug Administration (FDA or we) is confirming the effective date of December 4, 2018, for the final rule that appeared in the Federal Register of November 1, 2018, and that amended the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules.
550 This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Bipartisan Budget Act of 2018; improve quality and accessibility; clarify certain program integrity policies for MA, Part D, and cost plans and PACE organizations; reduce burden on providers, MA plans, and Part D sponsors through providing additional policy clarification; and implement other technical changes regarding quality improvement. This final rule will also revise the appeals and grievances requirements for certain Medicaid managed care and MA special needs plans for dual eligible individuals to implement certain provisions of the Bipartisan Budget Act of 2018.
551 The Food and Drug Administration (FDA or we) is classifying the ventilatory electrical impedance tomograph into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the ventilatory electrical impedance tomograph's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
552 The Food and Drug Administration (FDA, we, or Agency) is classifying suitable accessories into class I as required by the FDA Reauthorization Act of 2017 (FDARA). The Agency has determined that general controls alone are sufficient to provide reasonable assurance of safety and effectiveness for these accessories. We made this determination based on the risks of the accessories when used as intended with other devices such as the parent or system.
553 The Food and Drug Administration (FDA, the Agency, or we) is issuing this final action establishing that certain active ingredients used in nonprescription (also known as over-the-counter (OTC)) consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are not eligible for evaluation under the OTC Drug Review for use in consumer antiseptic rubs. Drug products containing these ineligible active ingredients will require approval under a new drug application (NDA) or abbreviated new drug application (ANDA) prior to marketing. FDA is issuing this final action after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC), public comments on the Agency's notices of proposed rulemaking, and all data and information on OTC consumer antiseptic rub products that have come to the Agency's attention. This final action finalizes the 1994 tentative final monograph (TFM) for OTC consumer antiseptic rub drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM), as amended by the proposed rule published in the Federal Register (FR) of June 30, 2016 (2016 Consumer Antiseptic Rub proposed rule).
554 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the readability of the regulations.
555 The Food and Drug Administration (FDA, the Agency, or we) is correcting with technical amendments two final rules that published in the Federal Register of September 17, 2015, and one final rule that published in the Federal Register of November 27, 2015. The final rules published with editorial and inadvertent errors. This document corrects those errors.
556 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug and device establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
557 The Food and Drug Administration (FDA or we) is reinstating the provision removed by our October 2018 final rule to amend the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp. This action does not reflect any change in our determination that new data demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive. We are reinstating this provision only because it was removed from the Code of Federal Regulations before we had the opportunity to take final action on the objections we received to the October 2018 final rule. This provision is being reinstated pending final FDA action on objections to the final rule.
558 The Food and Drug Administration (FDA or Agency) is amending the medical device reports of corrections and removals regulation to correct three inaccurate cross-references. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
559 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. FDA is also establishing special controls in a special controls guideline in addition to restricting use and distribution of the devices. An in vitro diagnostic device for Bacillus spp. detection is a prescription device used to detect and differentiate among Bacillus spp. and presumptively identify B. anthracis and other Bacillus spp. from cultured isolates or clinical specimens as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp.
560 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify posterior cervical screw systems into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term "posterior cervical screw systems" is used to distinguish these devices from currently classified thoracolumbosacral pedicle screw systems for use in other spinal regions.
561 This interim final rule with comment period revises the regulatory text to accurately reflect the applicable statutory language describing the rebate calculation for line extension drugs, which was revised by the Bipartisan Budget Act (BBA) of 2018. In addition, we also are issuing a final rule which responds to comments on the definition and identification of line extension drugs for which we requested additional comments in the Covered Outpatient Drugs final rule with comment period published in the February 1, 2016 Federal Register.
562 The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled "Produce Safety Rule: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds." This document states the intent of FDA to exercise enforcement discretion regarding the requirements of the "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" regulation (Produce Safety Regulation) as they apply to entities growing, harvesting, packing, and holding hops, wine grapes, pulse crops, and almonds.
563 This final rule amends the regulation governing State Medicaid Fraud Control Units (MFCUs or Units). The rule incorporates statutory changes affecting the Units as well as policy and practice changes that have occurred since the regulation was initially issued in 1978. These changes include a recognition of OIG's delegated authority; Unit authority, functions, and responsibilities; disallowances; and issues related to organization, prosecutorial authority, staffing, recertification, and the Units' relationship with Medicaid agencies. The rule is designed to assist the MFCUs in understanding their authorities and responsibilities under the grant program, clarify the flexibilities the MFCUs have to operate their programs, and reduce administrative burden, where appropriate, by eliminating duplicative and unnecessary reporting requirements.
564 The Food and Drug Administration (FDA, the Agency, or we) is extending, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" rule. We are extending the compliance dates to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to protect public health.
565 This document corrects technical errors in the "Evaluation and Management Services" provisions that appeared in the final rule with comment period published in the Federal Register on November 23, 2018, concerning changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute.
566 The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microorganisms and associated resistance marker nucleic acids directly in respiratory specimens classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
567 The Food and Drug Administration (FDA or we) is classifying the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
568 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the readability of the regulations.
569 The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and an abbreviated new animal drug application (ANADA) at the sponsors' request because these products are no longer manufactured or marketed.
570 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of selenomethionine hydroxy analogue as a source of selenium in feed for chickens, turkeys, and swine, as well as to provide for the safe use of silicon dioxide as a carrier for selenomethionine hydroxy analogue. This action is in response to a food additive petition filed by Adisseo France S.A.S.
571 The Food and Drug Administration (FDA or we) is classifying the software application for contraception into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the software application for contraception's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
572 The Food and Drug Administration (FDA or Agency) is amending its regulations to reflect a change of address for the Center for Drug Evaluation and Research's (CDER's) Office of Generic Drugs (OGD) Document Room from Rockville, MD, to Beltsville, MD. This action is being taken to ensure accuracy and clarity in the Agency's regulations.
573 The Food and Drug Administration (FDA, we, or Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of gamma- linolenic acid safflower oil (GLA safflower oil) as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage. This action is in response to a food additive petition filed by Arcadia Biosciences, Inc.
574 The Food and Drug Administration (FDA or we) is classifying the auto titration device for oral appliances into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the auto titration device for oral appliances' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
575 The Food and Drug Administration (FDA or the Agency) is issuing a final rule to establish criteria for and identify an initial list of bulk drug substances that can be used to compound drug products in accordance with certain compounding provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act), although they are neither the subject of an applicable United States Pharmacopeia (USP) or National Formulary (NF) monograph nor components of FDA-approved drugs. Specifically, the Agency is placing six bulk drug substances on the list. This final rule also identifies four bulk drug substances that FDA has considered and is not including on the list. Additional bulk drug substances nominated by the public for inclusion on this list are currently under consideration and will be the subject of a future rulemaking.
576 This document corrects technical errors that appeared in the final rule published in the Federal Register on November 23, 2018 entitled "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program-- Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; provisions from the Medicare Shared Savings Program-- Accountable Care Organizations Pathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act."
577 Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. The policies included in this final rule provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses). These policies are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free-market principles. This final rule also provides new tools to support coordination of care across settings and strengthen beneficiary engagement; and ensure rigorous benchmarking. In this final rule, we also respond to public comments we received on the extreme and uncontrollable circumstances policies for the Shared Savings Program that were used to assess the quality and financial performance of ACOs that were subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, in performance year 2017, including the applicable quality data reporting period for performance year 2017.
578 This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 14, 2018 titled "Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals With Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Competitive Bidding Program (CBP) and Fee Schedule Amounts, and Technical Amendments To Correct Existing Regulations Related to the CBP for Certain DMEPOS."
579 This document corrects technical and typographical errors in the final rule with comment period that appeared in the November 21, 2018 Federal Register titled "Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs."
580 The Food and Drug Administration (FDA) is amending the food additive regulations for a required labeling statement for use of formic acid in complete feed for swine and poultry. This action is being taken to improve the accuracy and clarity of the regulations.
581 The Food and Drug Administration (FDA) is issuing a final order to reclassify the electroconvulsive therapy (ECT) device for use in treating catatonia or a severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years and older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition, which is a preamendments class III device, into class II (special controls). FDA is also issuing this final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the preamendments class III ECT devices for all other uses that are not being reclassified to class II (product code GXC).
582 The Food and Drug Administration (FDA or we) is amending the regulations pertaining to the Nutrition Facts and Supplement Facts labels. The amendments correct errors that were made in labeling examples, restore incorrect deletions, correct the edition of a reference cited in the rule, and correct cross-references to other regulations. This action is ministerial or editorial in nature.
583 The Food and Drug Administration (FDA or we) is establishing January 1, 2022, as the uniform compliance date for food labeling regulations that are published on or after January 1, 2019, and on or before December 31, 2020. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes.
584 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy and readability of the regulations.
585 The Food and Drug Administration (FDA or we) is confirming the effective date of October 26, 2018, for the final rule that appeared in the Federal Register of September 25, 2018, and that amended the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution.
586 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.
587 The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. Drug products appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the final rule adds two entries to this list of drug products.
588 This document corrects an error that appeared in the final rule with comment period published in the Federal Register on November 21, 2018, entitled "Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs." Specifically, this document corrects the public comment period end date. The corrected date is January 2, 2019.
589 This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also finalizes policies included in the interim final rule with comment period in "Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year" that address the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria. In addition, this final rule addresses a subset of the changes to the Medicare Shared Savings Program for Accountable Care Organizations (ACOs) proposed in the August 2018 proposed rule "Medicare Program; Medicare Shared Savings Program; Accountable Care Organizations--Pathways to Success". This final rule also addresses certain other revisions designed to update program policies under the Shared Savings Program. The interim final rule implements amendments made by the SUPPORT for Patients and Communities Act to the Medicare telehealth provisions in the Social Security Act and regarding permissible telehealth originating sites for purposes of treatment of a substance use disorder or a co-occurring mental health disorder for telehealth services furnished on or after July 1, 2019 to an individual with a substance use disorder diagnosis.
590 This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2019 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, we are updating the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey measure under the Hospital Inpatient Quality Reporting (IQR) Program by removing the Communication about Pain questions; and retaining two measures that were proposed for removal, the Catheter-Associated Urinary Tract Infection (CAUTI) Outcome Measure and Central Line-Associated Bloodstream Infection (CLABSI) Outcome Measure, in the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program beginning with the FY 2021 program year.
591 This final rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2019. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, it updates and rebases the ESRD market basket for CY 2019. This rule also updates requirements for the ESRD Quality Incentive Program (QIP), and makes technical amendments to correct existing regulations related to the Competitive Bidding Program (CBP) for certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). Finally, this rule finalizes changes to bidding and pricing methodologies under the DMEPOS competitive bidding program; adjustments to DMEPOS fee schedule amounts using information from competitive bidding for items furnished from January 1, 2019 through December 31, 2020; new payment classes for oxygen and oxygen equipment and a new methodology for ensuring that new payment classes for oxygen and oxygen equipment are budget neutral; payment rules for multi- function ventilators or ventilators that perform functions of other durable medical equipment (DME); and revises the payment methodology for mail order items furnished in the Northern Mariana Islands. This rule also includes a summary of the feedback received for the request for information related to establishing fee schedule amounts for new DMEPOS items and services.
592 The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Sensient Colors, LLC, proposing that the color additive regulations be amended to provide for the safe use of an aqueous extract of butterfly pea flower (Clitoria ternatea) as a color additive in various food categories, at levels consistent with good manufacturing practice.
593 This final rule with comment period updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60-day episode payment rates, the national per- visit rates, and the non-routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2019. This rule also: Updates the HH PPS case-mix weights for calendar year (CY) 2019 using the most current, complete data available at the time of rulemaking; discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CYs 2014 through 2017; finalizes a rebasing of the HH market basket (which includes a decrease in the labor-related share); finalizes the methodology used to determine rural add-on payments for CYs 2019 through 2022, as required by section 50208 of the Bipartisan Budget Act of 2018 (Pub. L. 115-123) hereinafter referred to as the "BBA of 2018"; finalizes regulations text changes regarding certifying and recertifying patient eligibility for Medicare home health services; and finalizes the definition of "remote patient monitoring" and the recognition of the costs associated with it as allowable administrative costs. This rule also summarizes the case-mix methodology refinements for home health services beginning on or after January 1, 2020, which includes the elimination of therapy thresholds for payment and a change in the unit of payment from a 60-day episode to a 30-day period, as mandated by section 51001 of the Bipartisan Budget Act of 2018. This rule also finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model. In addition, with respect to the Home Health Quality Reporting Program, this rule discusses the Meaningful Measures Initiative; finalizes the removal of seven measures to further the priorities of this initiative; discusses social risk factors and provides an update on implementation efforts for certain provisions of the IMPACT Act; and finalizes a regulatory text change regarding OASIS data. For the home infusion therapy benefit, this rule finalizes health and safety standards that home infusion therapy suppliers must meet; finalizes an approval and oversight process for accrediting organizations (AOs) that accredit home infusion therapy suppliers; finalizes the implementation of temporary transitional payments for home infusion therapy services for CYs 2019 and 2020; and responds to the comments received regarding payment for home infusion therapy services for CY 2021 and subsequent years. Lastly, in this rule, we are finalizing only one of the two new requirements we proposed to implement in the regulations for the oversight of AOs that accredit Medicare-certified providers and suppliers. More specifically, for reasons set out more fully in the section X. of this final rule with comment period, we have decided not to finalize our proposal to require that all surveyors for AOs that accredit Medicare-certified providers and suppliers take the same relevant and program-specific CMS online surveyor training that the State Agency surveyors are required to take. However, we are finalizing our proposal to require that each AO must provide a written statement with their application to CMS, stating that if one of its fully accredited providers or suppliers, in good- standing, provides written notification that they wish to voluntarily withdraw from the AO's CMS-approved accreditation program, the AO must continue the provider or supplier's current accreditation until the effective date of withdrawal identified by the facility or the expiration date of the term of accreditation, whichever comes first.
594 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Nutrition and Supplement Facts Labels: Questions and Answers Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals; Guidance for Industry." This guidance is intended for conventional food and dietary supplement manufacturers. The guidance finalizes the draft guidance we issued in January 2017, which provides questions and answers (Q&A) on topics related to compliance with the Nutrition Facts and Supplement Facts label and Serving Size final rules, the labeling of added sugars, declaration of quantitative amounts of vitamins and minerals, and format issues on the Nutrition Facts and Supplement Facts labels.
595 This document announces the extension of the timeline for publication of the "Medicare and Medicaid Program; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies" final rule. We are issuing this document in accordance with section 1871(a)(3)(B) of the Social Security Act (the Act), which requires notice to be provided in the Federal Register if there are exceptional circumstances that cause us to publish a final rule more than 3 years after the publication date of the proposed rule. In this case, the complexity of the rule and scope of public comments warrants the extension of the timeline for publication.
596 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of synthetic iron oxides as color additives to include use in dietary supplement tablets and capsules. This action is in response to a color additive petition (CAP) filed by Colorcon, Inc.
597 The Food and Drug Administration (FDA or we) is classifying the insulin therapy adjustment device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the insulin therapy adjustment device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
598 The Food and Drug Administration (FDA or we) is classifying the meprobamate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the meprobamate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
599 The Food and Drug Administration (FDA or we) is amending the color additive regulations to no longer provide for the use of lead acetate in cosmetics intended for coloring hair on the scalp because new data available since lead acetate was permanently listed demonstrate that there is no longer a reasonable certainty of no harm from the use of this color additive. This action is in response to a color additive petition filed by the Environmental Defense Fund, Earthjustice, Environmental Working Group, Center for Environmental Health, Healthy Homes Collaborative, Health Justice Project of Loyola University Chicago School of Law, Breast Cancer Fund, Improving Kids' Environment, Consumers Union, Natural Resources Defense Council, Consumer Federation of America, Learning Disabilities Association, Maricel Maffini, and Howard Mielke.
600 The Food and Drug Administration (FDA or we) is classifying the high flow humidified oxygen delivery device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the high flow humidified oxygen delivery device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
601 The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the active implantable bone conduction hearing system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
602 The Food and Drug Administration (FDA or we) is classifying the positive airway pressure delivery system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the positive airway pressure delivery system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
603 The Food and Drug Administration (FDA or we) is classifying the wound autofluorescence imaging device into class I. We are taking this action because we have determined that classifying the device into class I will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
604 The Food and Drug Administration (FDA or we) is classifying the light based energy source device for topical application into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the light based energy source device for topical application's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
605 The Food and Drug Administration (FDA or we) is classifying the hemostatic device for intraluminal gastrointestinal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hemostatic device for intraluminal gastrointestinal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
606 The Food and Drug Administration (FDA or we) is classifying the thermal vestibular stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the thermal vestibular stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
607 The Food and Drug Administration (FDA or we) is classifying the intranasal electrostimulation device for dry eye symptoms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the intranasal electrostimulation device for dry eye symptoms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
608 The Food and Drug Administration (FDA or we) is classifying the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
609 The Food and Drug Administration (FDA or we) is classifying the external upper limb tremor stimulator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external upper limb tremor stimulator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
610 The Food and Drug Administration (FDA, the Agency, or we) is amending the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant for use in food because these uses have been abandoned. We are taking this action in response to a food additive petition submitted by the Styrene Information and Research Center (SIRC).
611 The Food and Drug Administration (FDA, the Agency, or we) is partially granting a petition submitted by the Breast Cancer Fund (now known as the Breast Cancer Prevention Partners), Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Consumers Union, Environmental Defense Fund, Environmental Working Group, Improving Kids' Environment, Natural Resources Defense Council, WE ACT for Environmental Justice, and Mr. James Huff, by amending the food additive regulations to no longer authorize the use of benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine as synthetic flavoring substances for use in food. We are taking this action because, despite FDA's scientific analysis and determination that these substances do not pose a risk to public health under the conditions of their intended use, the petitioners provided data demonstrating that these additives induce cancer in laboratory animals, and, as a result of this finding in animals, FDA cannot as a matter of law maintain the listing of these synthetic flavoring substances in the food additive regulations. Because of evidence that benzophenone causes cancer in animals, FDA also is amending the food additive regulations to no longer provide for the use of benzophenone as a plasticizer in rubber articles intended for repeated use in contact with food. FDA is denying as moot the portions of the petition proposing that the food additive regulations be amended to no longer authorize the use of styrene as a synthetic flavoring substance because this use has been permanently and completely abandoned. In addition, FDA is declining to act on the petitioners' request to issue a regulation to prohibit the use of these synthetic flavoring substances in food because that issue is not the proper subject of a food additive petition.
612 This document corrects technical errors in the final rule that appeared in the August 8, 2018 Federal Register (83 FR 39162) entitled "Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Final Rule for FY 2019, SNF Value- Based Purchasing Program, and SNF Quality Reporting Program."
613 This document corrects technical and typographical errors in the final rule that appeared in the August 17, 2018 issue of the Federal Register titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims".
614 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of 25- hydroxyvitamin D<INF>3</INF> as a source of vitamin D<INF>3</INF> activity for layer and breeder chickens and turkeys. This action is in response to two food additive petitions filed by DSM Nutritional Products.
615 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January, February, and March 2018. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name, and to make technical amendments to improve the accuracy of the regulations.
616 The Food and Drug Administration (FDA) is withdrawing approval of 12 new animal drug applications (NADAs) at the sponsor's request because these products are no longer manufactured or marketed.
617 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify single-use female condoms, renaming the device to "single-use internal condom," a postamendments class III device (regulated under product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. FDA is also amending the existing device identification for "female condom," a preamendments class III device (product code OBY), by renaming the device "multiple-use female condom," to distinguish it from the "single-use internal condom." This order reclassifies single-use internal condoms from class III to class II and reduces regulatory burden because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome 510(k) before marketing their device.
618 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of D&C Yellow No. 8 as a color additive in contact lens solution. We are taking this action in response to a color additive petition submitted by Glo Eyes, LLC.
619 The Food and Drug Administration (FDA or we) is amending the food additive regulation for vitamin D<INF>3</INF> to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D<INF>3</INF> specifications. We are taking this action in response to a food additive petition filed by the Juice Products Association.
620 The Food and Drug Administration (FDA or we) is confirming the effective date of July 10, 2018, for the final rule that appeared in the Federal Register of June 7, 2018, and that amended the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non- absorbable sutures for use in general surgery.
621 The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a final guidance for industry entitled "Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food and Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals; Guidance for Industry." This guidance explains our current thinking on how to determine whether a facility is a "qualified facility" that is subject to modified requirements under our rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" (the Preventive Controls for Human Food Rule) or under our rule entitled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals" (the Preventive Controls for Animal Food Rule). This guidance also explains our current thinking on how a facility would submit Form FDA 3942a, attesting to its status as a qualified facility under the Preventive Controls for Human Food Rule and how a business would submit Form FDA 3942b, attesting to its status as a qualified facility under the Preventive Controls for Animal Food Rule.
622 The Food and Drug Administration (FDA, the Agency, or we) is removing instruction 13 from the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (Preventive Controls for Human Food) regulation. Instruction 13 directs the Federal Register to remove and reserve as of September 17, 2018, the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (Human Food CGMP) regulation. Removal of instruction 13 is necessary because the compliance dates for certain facilities subject to the modernized current good manufacturing practice requirements in the Preventive Controls for Human Food regulation have been extended. Retaining the Human Food CGMP regulation will maintain the status quo while these facilities prepare for compliance with the new CGMP requirements and will avoid an unintended gap in public health protection.
623 This document announces changes to the payment adjustment for low-volume hospitals under the hospital inpatient prospective payment systems (IPPS) for acute care hospitals for fiscal years (FYs) 2011 through 2017 in accordance with section 429 of the Consolidated Appropriations Act, 2018.
624 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Questions and Answers Regarding Food Facility Registration (Seventh Edition)." The guidance provides updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
625 This document announces revisions to the Provider Enrollment Moratoria Access Waiver Demonstration (PEWD) for Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies. The demonstration was implemented in accordance with section 402(a)(1)(J) of the Social Security Amendments of 1967 and, as revised, gives CMS the authority to grant waivers to the statewide enrollment moratoria on a case-by-case basis in response to access to care issues and previously denied enrollment applications because of statewide moratoria implementation, and to subject providers and suppliers enrolling via such waivers to heightened screening, oversight, and investigations.
626 The Food and Drug Administration's (FDA, Agency, or we) Center for Devices and Radiological Health and Center for Biologics Evaluation and Research are announcing that the Agency is granting an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in summary form on a quarterly basis. We refer to this alternative as the "Voluntary Malfunction Summary Reporting Program." This voluntary program reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments of 2017 (MDUFA IV Commitment Letter).
627 We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2019. Some of these changes implement certain statutory provisions contained in the 21st Century Cures Act and the Bipartisan Budget Act of 2018, and other legislation. We also are making changes relating to Medicare graduate medical education (GME) affiliation agreements for new urban teaching hospitals. In addition, we are providing the market basket update that will apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2019. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long- term care hospitals (LTCHs) for FY 2019. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (now referred to as the Promoting Interoperability Programs). In addition, we are finalizing modifications to the requirements that apply to States operating Medicaid Promoting Interoperability Programs. We are updating policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital- Acquired Condition (HAC) Reduction Program. We also are making changes relating to the required supporting documentation for an acceptable Medicare cost report submission and the supporting information for physician certification and recertification of claims.
628 This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019. This final rule also replaces the existing case-mix classification methodology, the Resource Utilization Groups, Version IV (RUG-IV) model, with a revised case-mix methodology called the Patient-Driven Payment Model (PDPM) beginning on October 1, 2019. The rule finalizes revisions to the regulation text that describes a beneficiary's SNF "resident" status under the consolidated billing provision and the required content of the SNF level of care certification. The rule also finalizes updates to the SNF Quality Reporting Program (QRP) and the Skilled Nursing Facility Value-Based Purchasing (VBP) Program.
629 This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2019. As required by the Social Security Act (the Act), this final rule includes the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2019. This final rule also alleviates administrative burden for IRFs by removing the Functional Independence Measure (FIM\\TM\\) instrument and associated Function Modifiers from the IRF Patient Assessment Instrument (IRF-PAI) beginning in FY 2020 and revises certain IRF coverage requirements to reduce the amount of required paperwork in the IRF setting beginning in FY 2019. Additionally, this final rule incorporates certain data items located in the Quality Indicators section of the IRF-PAI into the IRF case-mix classification system using analysis of 2 years of data beginning in FY 2020. For the IRF Quality Reporting Program (QRP), this final rule adopts a new measure removal factor, removes two measures from the IRF QRP measure set, and codifies a number of program requirements in our regulations.
630 This final rule updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital. These changes are effective for IPF discharges occurring during the fiscal year (FY) beginning October 1, 2018 through September 30, 2019 (FY 2019). This final rule also updates the IPF labor-related share, the IPF wage index for FY 2019, and the International Classification of Diseases 10th Revision, Clinical Modification (ICD- 10-CM) codes for FY 2019. It also makes technical corrections to the IPF regulations, and updates quality measures and reporting requirements under the Inpatient Psychiatric Facility Quality Reporting (IPFQR) Program. In addition, it updates providers on the status of IPF PPS refinements.
631 This final rule updates the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2019. The rule also makes conforming regulations text changes to recognize physician assistants as designated hospice attending physicians effective January 1, 2019. Finally, the rule includes changes to the Hospice Quality Reporting Program.
632 This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non- emergency ground ambulance suppliers and home health agencies and branch locations in Medicaid and the Children's Health Insurance Program in those states.
633 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry #252 entitled "Antimicrobial Animal Drug Sales and Distribution Reporting Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule we issued in the Federal Register of May 11, 2016, entitled "Antimicrobial Animal Drug Sales and Distribution Reporting."
634 The Food and Drug Administration (FDA or we) is classifying the next generation sequencing based tumor profiling test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the next generation sequencing based tumor profiling test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
635 The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fluid jet system for prostate tissue removal's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
636 The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry." The guidance identifies eight specific, additional isolated or synthetic non-digestible carbohydrates that we intend to add to our regulatory definition of "dietary fiber" through our regular rulemaking process. In the interim, the guidance also advises manufacturers of our policy for when one or more of these eight non-digestible carbohydrates, present in a food, are included in the declared amount of "dietary fiber," and for the use of a caloric value for polydextrose of 1 kilocalorie per gram (kcal/g).
637 This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on April 16, 2018 titled "Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program."
638 The Food and Drug Administration (FDA or we) is classifying the brain trauma assessment test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain trauma assessment test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
639 The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic electrosurgical clip cutting system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
640 The Food and Drug Administration (FDA or we) is classifying the in vivo cured intramedullary fixation rod into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the in vivo cured intramedullary fixation rod's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
641 The Food and Drug Administration (FDA or we) is classifying the microneedling device for aesthetic use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the microneedling device for aesthetic use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
642 This final rule finalizes a policy that provides flexibility in the determination of episode spending for Comprehensive Care for Joint Replacement Payment Model (CJR) participant hospitals located in areas impacted by extreme and uncontrollable circumstances for performance years 3 through 5.
643 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non- absorbable sutures for use in general surgery. This action is in response to a color additive petition (CAP) submitted by DSM Biomedical.
644 The Food and Drug Administration (FDA or the Agency) is publishing an order to exempt a list of class II devices from premarket notification (510(k)) requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for the listed class II devices. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the listed class II devices to reflect this final determination. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
645 This document announces the addition of 31 Healthcare Common Procedure Coding System (HCPCS) codes to the Required Prior Authorization List of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Items that require prior authorization as a condition of payment. Prior authorization for these codes will be implemented nationwide.
646 This document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 16, 2017 entitled "Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year" (hereinafter referred to as the "CY 2018 Quality Payment Program final rule").
647 Based on the available scientific evidence and the findings of expert scientific panels, the Food and Drug Administration (FDA or we) made a final determination that there is no longer a consensus among qualified experts that partially hydrogenated oils (PHOs), which are the primary dietary source of industrially produced trans fatty acids (IP-TFA), are generally recognized as safe (GRAS) for any use in human food. In a declaratory order announcing our final determination, we set a compliance date of June 18, 2018. We are now extending the compliance date for certain uses of PHOs.
648 The Food and Drug Administration (FDA, Agency, or we) is issuing a final rule to classify blood establishment computer software (BECS) and BECS accessories (regulated under product code MMH) into class II (special controls). FDA has identified special controls for BECS and BECS accessories that are necessary to provide a reasonable assurance of safety and effectiveness. FDA is also giving notice that the Agency does not intend to exempt BECS and BECS accessories from premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
649 The Food and Drug Administration (FDA or Agency) is publishing this final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions and limitations. FDA is limiting the exemption to single-use, disposable respiratory protective devices (RPD) used in a healthcare setting and worn by healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. These devices, commonly referred to as N95 filtering facepiece respirators (FFRs) and surgical N95 respirators (herein collectively referred to as N95s) are currently regulated by FDA under product code MSH. This exemption will decrease regulatory burden on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. All other class II devices classified under FDA's surgical apparel classification regulation continue to be subject to premarket notification requirements. FDA is also amending the codified language for the surgical apparel devices classification regulation to reflect this final determination.
650 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "The FDA Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules: What You Need to Know About the Food and Drug Administration Regulation--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled "The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification for Certain Provisions of Four Implementing Rules."
651 This interim final rule with comment period makes technical amendments to the regulation to reflect the extension of the transition period from June 30, 2016 to December 31, 2016 that was mandated by the 21st Century Cures Act for phasing in fee schedule adjustments for certain durable medical equipment (DME) and enteral nutrition paid in areas not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). In addition, this interim final rule with comment period amends the regulation to resume the transition period's blended fee schedule rates for items furnished in rural areas and non-contiguous areas (Alaska, Hawaii, and United States territories) not subject to the CBP from June 1, 2018 through December 31, 2018. This interim final rule with comment period also makes technical amendments to existing regulations for DMEPOS items and services to reflect the exclusion of infusion drugs used with DME from the DMEPOS CBP.
652 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Menu Labeling: Supplemental Guidance for Industry." The guidance addresses stakeholder concerns regarding the implementation of nutrition labeling required for foods sold in covered establishments, includes expanded and new examples of alternatives to aid in compliance, identifies places where we intend to be more flexible in our approach, and advises of our intent to exercise enforcement discretion regarding nutrient declaration for "calories from fat" as part of the additional written nutrition information. The guidance also includes many graphical depictions to convey our thinking on various topics and to provide examples of options for implementation, and addresses calorie disclosure signage for self-service foods, including buffets and grab- and-go foods; reasonable basis, and the criteria for considering the natural variation of foods, when determining nutrition labeling for such foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer.
653 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of dried marine microalgae as a source of docosahexaenoic acid (DHA) for use in complete, dry foods for adult dogs. This action is in response to a food additive petition filed by DSM Nutritional Products.
654 The Food and Drug Administration (FDA) published in the Federal Register of January 26, 2018, a direct final rule to amend the general biologics regulations relating to time of inspection requirements and to also remove duties of inspector requirements. The comment period closed April 11, 2018. FDA is withdrawing the direct final rule because the Agency received significant adverse comment.
655 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify the needle destruction device, renaming the device to "sharps needle destruction device," a postamendments class III device (regulated under product code MTV), into class II (special controls), subject to premarket notification. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is finalizing this reclassification on its own initiative based on new information. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device. This order reclassifies these types of devices from class III to class II and will reduce regulatory burdens on industry because these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a less burdensome premarket notification (510(k)) before marketing their device.
656 The Food and Drug Administration (FDA or we) is extending the compliance dates by approximately 1.5 years for the final rules providing updated nutrition information on the label of food, including dietary supplements; defining a single-serving container; requiring dual-column labeling for certain containers; updating, modifying, and establishing certain reference amounts customarily consumed (RACCs); and amending the label serving size for breath mints. The final rules appeared in the Federal Register of May 27, 2016. We are taking this action because, after careful consideration, we have determined that additional time would help ensure that all manufacturers covered by the final rules have guidance from FDA to address, for example, certain technical questions we received after publication of the final rules, and that they have sufficient time to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules.
657 The Food and Drug Administration (FDA or we) is amending the common or usual name regulation for crabmeat by replacing "brown king crabmeat" with "golden king crabmeat" as the common or usual name for crabmeat derived from the species Lithodes aequispinus. We are taking this action due to a recently enacted law. We are also correcting an error in the placement of a scientific term, which is editorial in nature.
658 This document corrects a technical error that appeared in the final rule published in the Federal Register on July 5, 2017 entitled "Medicaid/CHIP Program; Medicaid Program and Children's Health Insurance Program (CHIP); Changes to the Medicaid Eligibility Quality Control and Payment Error Rate Measurement Programs in Response to the Affordable Care Act" (hereinafter referred to as the "PERM final rule").
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660 This final rule will revise the Medicare Advantage (MA) program (Part C) regulations and Prescription Drug Benefit program (Part D) regulations to implement certain provisions of the Comprehensive Addiction and Recovery Act (CARA) to further reduce the number of beneficiaries who may potentially misuse or overdose on opioids while still having access to important treatment options; implement certain provisions of the 21st Century Cures Act; support innovative approaches to improve program quality, accessibility, and affordability; offer beneficiaries more choices and better care; improve the CMS customer experience and maintain high beneficiary satisfaction; address program integrity policies related to payments based on prescriber, provider and supplier status in MA, Medicare cost plan, Medicare Part D and the PACE programs; provide an update to the official Medicare Part D electronic prescribing standards; and clarify program requirements and certain technical changes regarding treatment of Medicare Part A and Part B appeal rights related to premiums adjustments.
661 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during October, November, and December 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and a change of a sponsor's name and address.
662 The Food and Drug Administration (FDA or Agency) is amending certain medical device regulations. This action is editorial in nature to correct typographical errors and to ensure accuracy and clarity in the Agency's regulations.
663 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July, August, and September 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the withdrawal of approval of applications, changes of sponsorship of applications, and a change of a sponsor's name and address, and to make technical amendments to improve the accuracy of the regulations.
664 The Food and Drug Administration (FDA) is withdrawing approval of three new animal drug applications (NADAs). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
665 This document announces the deletion of four Healthcare Common Procedure Coding System (HCPCS) codes from the Master List of Items Frequently Subject to Unnecessary Utilization that could be potentially subject to Prior Authorization as a condition of payment.
666 The Food and Drug Administration (FDA or Agency) is amending its good guidance practices regulation to inform the public on how to electronically submit a draft of a proposed guidance to the Agency. This technical amendment is nonsubstantive.
667 The Food and Drug Administration (FDA or Agency) is amending its Cigarettes, Smokeless Tobacco, and Covered Tobacco Products regulations to reflect a change of office name and mailing address for the Center for Tobacco Products' (CTP's) Office of Compliance and Enforcement. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
668 The Food and Drug Administration (FDA or Agency) is amending its regulations to reflect organizational change for the Office of Regulatory Policy, Center for Drug Evaluation and Research (CDER), Office of Medical Products and Tobacco. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.
669 The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a guidance for industry entitled "Application of the Foreign Supplier Verification Program Regulations to the Importation of Live Animals: Guidance for Industry." The purpose of this document is to state FDA's intent to exercise enforcement discretion regarding application of the regulation on foreign supplier verification programs (FSVPs) to importers of certain live animals. The enforcement discretion would apply to importers of live animals that are required to be slaughtered and processed at U.S. Department of Agriculture (USDA) regulated establishments subject to USDA-administered Hazard Analysis and Critical Control Point (HACCP) requirements, or at State-inspected establishments subject to requirements equivalent to the Federal standard.
670 The Food and Drug Administration (FDA or we) is announcing the availability of an immediately in effect guidance for industry entitled "Compliance Policy for Combination Product Postmarketing Safety Reporting." This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. This guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
671 The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule to delay the effective date of amendments to the existing medical product "intended use" regulations, contained in the final rule published January 9, 2017, until further notice. This final rule delays the effective date of the amendments to allow further consideration of the substantive issues raised in the comments received regarding the amendments. This action does not delay the effective date of the portions of the January 9, 2017, final rule that describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which remains March 19, 2018.
672 The Food and Drug Administration is correcting a final order entitled "Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems" that appeared in the Federal Register of February 27, 2018. The document was published with the incorrect docket number. This document corrects that error.
673 The Food and Drug Administration (FDA or Agency) is publishing an order granting a petition requesting exemption from premarket notification requirements for over-the-counter (OTC) denture repair kits (Product Code EBO). These devices consist of material, such as a resin monomer system of powder and liquid glues, which is intended to be applied permanently to a denture to mend cracks or breaks. This order exempts OTC denture repair kits, class II devices, from premarket notification (510(k)). This exemption from 510(k) is immediately in effect for OTC denture repair kits. FDA is publishing this order in accordance with the section of the Federal Food, Drug, and Cosmetic Act (FD&C Act) permitting the exemption of a device from the requirement to submit a 510(k).
674 The Food and Drug Administration (FDA or we) is classifying the extracorporeal shock wave device for treatment of chronic wounds into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the extracorporeal shock wave device for treatment of chronic wounds' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
675 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of silicon dioxide as a carrier for flavors for use in animal feed. This action is in response to a food additive petition filed by Idemitsu Kosan, Cp. Ltd.
676 The Food and Drug Administration (FDA or we) is classifying Lynch syndrome test systems into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Lynch syndrome test systems' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
677 The Food and Drug Administration (FDA or we) is amending its regulations on acceptance of data from clinical investigations for medical devices. We are requiring that data submitted from clinical investigations conducted outside the United States intended to support an investigational device exemption (IDE) application, a premarket notification (510(k)) submission, a request for De Novo classification, a premarket approval (PMA) application, a product development protocol (PDP) application, or a humanitarian device exemption (HDE) application be from investigations conducted in accordance with good clinical practice (GCP), which includes obtaining and documenting the review and approval of the clinical investigation by an independent ethics committee (IEC) and obtaining and documenting freely given informed consent of subjects, which includes individuals whose specimens are used in investigations of medical devices. The final rule updates the criteria for FDA acceptance of data from clinical investigations conducted outside the United States to help ensure the quality and integrity of data obtained from these investigations and the protection of human subjects. As part of this final rule, we are also amending the IDE, 510(k), and HDE regulations to address the requirements for FDA acceptance of data from clinical investigations conducted inside the United States. The final rule provides consistency in FDA requirements for acceptance of data from clinical investigations, whatever the application or submission type.
678 The Food and Drug Administration (FDA or we) is classifying the non-absorbable, hemostatic gauze for temporary internal use into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-absorbable, hemostatic gauze for temporary internal use's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
679 The Food and Drug Administration (FDA or we) is classifying the percutaneous nerve stimulator for substance use disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the percutaneous nerve stimulator for substance use disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
680 The Food and Drug Administration (FDA or we) is confirming the effective date of December 8, 2017, for the final rule that appeared in the Federal Register of November 7, 2017, and that amended the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and in inks used on the surface of chewing gum.
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682 The Food and Drug Administration (FDA or we) is classifying the temporary catheter for embolic protection during transcatheter intracardiac procedures into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the temporary catheter for embolic protection during transcatheter intracardiac procedures' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
683 This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states. For purposes of these moratoria, providers that were participating as network providers in one or more Medicaid managed care organizations prior to January 1, 2018 will not be considered "newly enrolling" when they are required to enroll with the State Medicaid agency pursuant to a new statutory requirement, and thus will not be subject to the moratoria.
684 The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the surgical smoke precipitator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
685 The Food and Drug Administration (FDA, Agency, or we) is amending the general biologics regulations relating to time of inspection requirements and also removing duties of inspector requirements. FDA is taking this action to remove outdated requirements and accommodate new approaches, such as a risk-based inspection frequency for drug establishments, thereby providing flexibility without diminishing public health protections. This action is part of FDA's implementation of Executive Orders (E.O.s) 13771 and 13777. Under these E.O.s, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction while allowing the Agency to achieve our public health mission and fulfill statutory obligations. The Agency is issuing these amendments directly as a final rule because we believe they are noncontroversial and FDA anticipates no significant adverse comments.
686 The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance for industry and FDA Staff entitled "Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff." This guidance describes FDA's intention with respect to the enforcement of unique device identification requirements for certain class I and unclassified devices. FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements under Agency regulations for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements under an Agency regulation for these devices before September 24, 2022. The policy described in this guidance does not apply to implantable, life-supporting, or life-sustaining devices. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
687 The Food and Drug Administration (FDA or we) is classifying the absorbable perirectal spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the absorbable perirectal spacer's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
688 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs." This guidance states agency compliance policy regarding certain entities and/or activities related to the "farm" definition, written assurances, food contact substances, and human food by-products for use as animal food.
689 The Food and Drug Administration (FDA or we) is classifying the cervical intraepithelial neoplasia (CIN) test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the CIN test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
690 The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid as a feed acidifying agent in complete poultry feeds. This action is in response to a food additive petition filed by BASF Corp.
691 The Food and Drug Administration (FDA or we) is classifying the whole slide imaging system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the whole slide imaging system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
692 The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the irrigating wound retractor device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
693 The Food and Drug Administration (FDA or we) is classifying the pressure wedge for the reduction of cesarean delivery into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the pressure wedge for the reduction of cesarean delivery's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
694 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule amending the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Under this final rule, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This final rule will help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
695 The Food and Drug Administration (FDA or we) is classifying the reagents for molecular diagnostic instrument test systems into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
696 The Food and Drug Administration (FDA or we) is classifying the flow cytometric test system for hematopoietic neoplasms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the flow cytometric test system for hematopoietic neoplasms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
697 The Food and Drug Administration (FDA or we) is classifying the computerized behavioral therapy device for psychiatric disorders into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the computerized behavioral therapy device for psychiatric disorders' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
698 The Food and Drug Administration (FDA or we) is classifying the external vagal nerve stimulator for headache into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external vagal nerve stimulator for headache's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
699 The Food and Drug Administration (FDA or we) is classifying the rectal balloon for prostate immobilization into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the rectal balloon for prostate immobilization's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
700 This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on December 14, 2017 entitled "Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs."
701 The Food and Drug Administration (FDA or we) is classifying the external negative pressure airway aid into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the external negative pressure airway aid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
702 This interim final rule with comment period establishes policies for assessing the financial and quality performance of Medicare Shared Savings Program (Shared Savings Program) Accountable Care Organizations (ACOs) affected by extreme and uncontrollable circumstances during performance year 2017, including the applicable quality reporting period for the performance year. Under the Shared Savings Program, providers of services and suppliers that participate in ACOs continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. ACOs in performance-based risk agreements may also share in losses. This interim final rule with comment period establishes extreme and uncontrollable circumstances policies for the Shared Savings Program that will apply to ACOs subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, effective for performance year 2017, including the applicable quality data reporting period for the performance year.
703 The Food and Drug Administration (FDA or we) is classifying the image processing device for estimation of external blood loss into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the image processing device for estimation of external blood loss' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
704 The Food and Drug Administration (FDA, the Agency, or we) is issuing this final rule establishing that certain active ingredients used in nonprescription (also known as over-the-counter or OTC) antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are not generally recognized as safe and effective (GRAS/GRAE). FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC health care antiseptic products that have come to the Agency's attention. This final rule finalizes the 1994 tentative final monograph (TFM) for OTC health care antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM) as amended by the proposed rule published in the Federal Register (FR) of May 1, 2015 (2015 Health Care Antiseptic Proposed Rule (PR)).
705 The Food and Drug Administration (FDA or we) is classifying the fetal head elevator into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the fetal head elevator's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
706 The Food and Drug Administration (FDA or we) is classifying the tear electrostimulation device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the tear electrostimulation device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
707 This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
708 The Food and Drug Administration (FDA) is announcing the termination of the Food Advisory Committee. This document removes the Food Advisory Committee from the Agency's list of standing advisory committees.
709 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during May and June 2017. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to make technical amendments to improve the accuracy of the regulations.
710 This final rule cancels the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) Incentive Payment Model and rescinds the regulations governing these models. It also implements certain revisions to the Comprehensive Care for Joint Replacement (CJR) model, including: Giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model; technical refinements and clarifications for certain payment, reconciliation and quality provisions; and a change to increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (Advanced APM) track. An interim final rule with comment period is being issued in conjunction with this final rule in order to address the need for a policy to provide some flexibility in the determination of episode costs for providers located in areas impacted by extreme and uncontrollable circumstances.
711 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Sanitary Transportation of Human and Animal Food: What You Need to Know About the FDA Regulation--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled "Sanitary Transportation of Human and Animal Food."
712 The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception." The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.
713 The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff." The guidance provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, healthcare providers, and FDA staff, with FDA's current thinking on the regulatory criteria of minimal manipulation and homologous use. The guidance is intended to improve stakeholders' understanding of the definitions of minimal manipulation and homologous use and how the regulatory criteria apply to their HCT/Ps. It also informs manufacturers, healthcare providers, and other interested persons that the Agency generally intends to exercise enforcement discretion over the next 36 months under limited conditions, with respect to the investigational new drug (IND) application and premarket approval (biologics license application (BLA)) requirements, for certain HCT/Ps.
714 The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) established the Quality Payment Program for eligible clinicians. Under the Quality Payment Program, eligible clinicians can participate via one of two tracks: Advanced Alternative Payment Models (APMs); or the Merit-based Incentive Payment System (MIPS). We began implementing the Quality Payment Program through rulemaking for calendar year (CY) 2017. This final rule with comment period provides updates for the second and future years of the Quality Payment Program. In addition, we also are issuing an interim final rule with comment period (IFC) that addresses extreme and uncontrollable circumstances MIPS eligible clinicians may face as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria.
715 This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies such as changes to the Medicare Shared Savings Program, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this final rule includes policies necessary to begin offering the expanded Medicare Diabetes Prevention Program model.
716 The Food and Drug Administration (FDA or we) is classifying the prostatic artery embolization device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the prostatic artery embolization device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
717 The Food and Drug Administration (FDA or we) is classifying the automated indirect immunofluorescence microscope and software- assisted system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated indirect immunofluorescence microscope and software-assisted system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
718 The Food and Drug Administration (FDA, we, the Agency) is amending food additive regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid and ammonium formate. This action is in response to a food additive petition filed by BASF Corp for Feed Grade Sodium Formate (FAP 2286), which also proposed to amend the animal food additive regulations for formic acid and ammonium formate to limit formic acid and formate salts from all added sources.
719 This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.
720 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and chewing gum. We are taking this action in response to a color additive petition submitted by the Wm. Wrigley Jr. Company.
721 The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the total 25-hydroxyvitamin D mass spectrometry test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
722 The Food and Drug Administration (FDA, the Agency, or we) is classifying the genetic health risk assessment system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the genetic health risk assessment system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
723 The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination.
724 This final rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. This rule also: Updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the third year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between calendar year (CY) 2012 and CY 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. In addition, this rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). We are not finalizing the implementation of the Home Health Groupings Model (HHGM) in this final rule.
725 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food." The guidance announces that we do not intend to take enforcement action against a receiving facility that is a co-manufacturer and that is not in compliance with certain supply-chain program requirements in the "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food" and "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals" regulations (preventive controls regulations) for food manufactured for the brand owner, under certain circumstances, until November 6, 2019. Furthermore, we do not intend to take enforcement action under the Foreign Supplier Verification Programs (FSVP) regulation against an importer whose supply-chain program is subject to enforcement discretion under the preventive controls regulations until November 6, 2019.
726 The Food and Drug Administration (FDA or we) is classifying the BCR-ABL quantitation test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the BCR-ABL quantitation test's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
727 This rule updates and makes revisions to the end-stage renal disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2018. It also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). This rule also sets forth requirements for the ESRD Quality Incentive Program (QIP), including for payment years (PYs) 2019 through 2021.
728 The Food and Drug Administration (FDA or we) is classifying the Streptococcus spp. nucleic acid-based assay into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Streptococcus spp. nucleic acid-based assay's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
729 The Food and Drug Administration (FDA or we) is classifying the newborn screening test for severe combined immunodeficiency disorder (SCID) into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the newborn screening test for SCID's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
730 The Food and Drug Administration (FDA) is correcting a final order entitled "Medical Devices; Gastroenterology-Urology Devices; Classification of the Oral Removable Palatal Space Occupying Device for Weight Management and/or Weight Loss" that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.
731 The Food and Drug Administration (FDA or we) is classifying the acute kidney injury test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the acute kidney injury test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
732 The Food and Drug Administration (FDA or we) is classifying the non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the non-EEG physiological signal based seizure monitoring system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
733 The Food and Drug Administration (FDA or we) is classifying the Aquaporin-4 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Aquaporin-4 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
734 The Food and Drug Administration (FDA or we) is classifying the device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the device to detect and measure non- microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
735 The Food and Drug Administration (FDA or we) is classifying the mass spectrometer system for clinical use for the identification of microorganisms into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the mass spectrometer system for clinical use for the identification of microorganisms' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
736 The Food and Drug Administration (FDA or we) is classifying the zinc transporter 8 autoantibody immunological test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the zinc transporter 8 autoantibody immunological test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
737 The Food and Drug Administration (FDA or we) is classifying the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid into class II (special controls). The special controls that will apply to the device type are identified in this order and will be part of the codified language for the device to detect and identify microbial pathogen nucleic acids in cerebrospinal fluid's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
738 This final rule amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests.
739 The Food and Drug Administration (FDA or we) is classifying the organophosphate test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the organophosphate test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
740 The Food and Drug Administration (FDA or we) is classifying the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
741 The Food and Drug Administration (FDA or we) is classifying the automated image assessment system for microbial colonies on solid culture media into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the automated image assessment system for microbial colonies on solid culture media's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
742 The Food and Drug Administration (FDA or we) is classifying the enzyme packed cartridge into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the enzyme packed cartridge's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
743 The Food and Drug Administration (FDA) is correcting a final order entitled "Medical Devices; Neurological Devices; Classification of Cranial Motion Measurement Device" that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.
744 The Food and Drug Administration (FDA) is correcting a final order entitled "Medical Devices; Cardiovascular Devices; Classification of the Adjunctive Cardiovascular Status Indicator" that appeared in the Federal Register of July 28, 2017. The final order was published with an incorrect statement in the preamble about whether FDA planned to exempt the device from premarket notification requirements. This document corrects that error.
745 This document corrects technical and typographical errors in the final rule that appeared in the August 14, 2017, issue of the Federal Register, which will amend the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018.
746 This document corrects technical errors in the final rule that appeared in the August 4, 2017 Federal Register, which will update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018.
747 The Food and Drug Administration (FDA or we) is classifying the high intensity ultrasound system for prostate tissue ablation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the high intensity ultrasound system for prostate tissue ablation's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
748 The Food and Drug Administration (FDA or we) is confirming the effective date of August 3, 2017, for the final rule that appeared in the Federal Register of July 3, 2017, and that amended the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice.
749 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for a new animal drug application (NADA) and abbreviated new animal drug applications (ANADAs) during March and April 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address and to make technical amendments to improve the accuracy of the regulations.
750 In the September 6, 2016 Federal Register (81 FR 61538), we published an interim final rule (IFR) issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. This correcting amendment corrects a limited number of technical and typographical errors identified in the CMS provisions of the September 6, 2016 IFR.
751 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption: What You Need to Know About the FDA Regulation: Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption."
752 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Mitigation Strategies to Protect Food Against Intentional Adulteration: What You Need To Know About the FDA Regulation: Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled "Mitigation Strategies to Protect Food Against Intentional Adulteration."
753 The Food and Drug Administration (FDA or Agency) is amending the Medical Device Classification Procedures regulation to reflect a change in address for the Center for Devices and Radiological Health (CDRH). This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
754 The Food and Drug Administration (FDA or we or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of oil from a variety of bioengineered safflower as a source of omega-6 fatty acids in complete dry adult maintenance dog food. This action is in response to a food additive petition filed by Arcadia Biosciences, Inc.
755 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Ultrafiltered Milk in the Production of Standardized Cheeses and Related Cheese Products: Guidance for Industry." The guidance advises manufacturers who wish to use ultrafiltered milk (UF milk) or ultrafiltered nonfat milk (UF nonfat milk) in the production of standardized cheeses and related cheese products that, pending completion of a rulemaking regarding the use of UF milk in the production of these products, we intend to exercise enforcement discretion regarding the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products. We also intend to exercise enforcement discretion regarding the declaration of ingredients in the labeling of standardized cheeses and related cheese products when fluid UF milk and fluid UF nonfat milk are used as ingredients.
756 We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2018. Some of these changes implement certain statutory provisions contained in the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013, the Improving Medicare Post-Acute Care Transformation Act of 2014, the Medicare Access and CHIP Reauthorization Act of 2015, the 21st Century Cures Act, and other legislation. We also are making changes relating to the provider-based status of Indian Health Service (IHS) and Tribal facilities and organizations and to the low-volume hospital payment adjustment for hospitals operated by the IHS or a Tribe. In addition, we are providing the market basket update that will apply to the rate- of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2018. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2018. In addition, we are establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities). We also are establishing new requirements or revising existing requirements for eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) participating in the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs. We are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. We also are making changes relating to transparency of accrediting organization survey reports and plans of correction of providers and suppliers; electronic signature and electronic submission of the Certification and Settlement Summary page of the Medicare cost reports; and clarification of provider disposal of assets.
757 This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2018. It also revises and rebases the market basket index by updating the base year from 2010 to 2014, and by adding a new cost category for Installation, Maintenance, and Repair Services. The rule also finalizes revisions to the SNF Quality Reporting Program (QRP), including measure and standardized resident assessment data policies and policies related to public display. In addition, it finalizes policies for the Skilled Nursing Facility Value-Based Purchasing Program that will affect Medicare payment to SNFs beginning in FY 2019. The final rule also clarifies the regulatory requirements for team composition for surveys conducted for investigating a complaint and aligns regulatory provisions for investigation of complaints with the statutory requirements. The final rule also finalizes the performance period for the National Healthcare Safety Network (NHSN) Healthcare Personnel (HCP) Influenza Vaccination Reporting Measure included in the End-Stage Renal Disease (ESRD) Quality Incentive Program (QIP) for Payment Year 2020.
758 This final rule will update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2018. Additionally, this rule includes new quality measures and provides an update on the hospice quality reporting program.
759 This final rule updates the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2018 as required by the statute. As required by section 1886(j)(5) of the Social Security Act (the Act), this rule includes the classification and weighting factors for the IRF prospective payment system's (IRF PPS) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2018. This final rule also revises the International Classification of Diseases, 10th Revision, Clinical Modification (ICD- 10-CM) diagnosis codes that are used to determine presumptive compliance under the "60 percent rule," removes the 25 percent payment penalty for inpatient rehabilitation facility patient assessment instrument (IRF-PAI) late transmissions, removes the voluntary swallowing status item (Item 27) from the IRF-PAI, summarizes comments regarding the criteria used to classify facilities for payment under the IRF PPS, provides for a subregulatory process for certain annual updates to the presumptive methodology diagnosis code lists, adopts the use of height/weight items on the IRF-PAI to determine patient body mass index (BMI) greater than 50 for cases of single-joint replacement under the presumptive methodology, and revises and updates measures and reporting requirements under the IRF quality reporting program (QRP).
760 The Food and Drug Administration (FDA) is classifying the adjunctive cardiovascular status indicator into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the adjunctive cardiovascular status indicator's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
761 The Food and Drug Administration (FDA or Agency) is classifying the oral removable palatal space occupying device for weight management and/or weight loss into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the oral removable palatal space occupying device for weight management and/or weight loss classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
762 The Food and Drug Administration (FDA or Agency) is classifying the cranial motion measurement device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the cranial motion measurement device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
763 The Food and Drug Administration (FDA, Agency, or we) is classifying the closed loop hysteroscopic insufflator with cutter- coagulator into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the closed loop hysteroscopic insufflator with cutter-coagulator classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
764 This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states.
765 The Food and Drug Administration (FDA, Agency, or we) is classifying the assayed quality control material for clinical microbiology assays into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the assayed quality control material for clinical microbiology assays' classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
766 The Food and Drug Administration (FDA, Agency, or we) is classifying the balloon aortic valvuloplasty catheter into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the balloon aortic valvuloplasty catheter's classification. The Agency is classifying the device into class II (special controls) to provide a reasonable assurance of safety and effectiveness of the device.
767 The Food and Drug Administration is correcting a document entitled "Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Comment Period" that appeared in the Federal Register of July 3, 2017. The document extended the comment period for the interim final rule that appeared in the Federal Register of May 4, 2017. The document was published with an incorrect RIN number. This document corrects that error.
768 The Food and Drug Administration (FDA or Agency) is amending a civil money penalty regulation to correct a statutory reference to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and to ensure accuracy and clarity in the Agency's regulations.
769 In the October 4, 2016 issue of the Federal Register, we published a final rule revising the requirements that Long-Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. The effective date was November 28, 2016. This document corrects technical and typographical errors identified in the October 4, 2016 final rule.
770 This final rule delays the effective date for the final rule entitled "Medicare and Medicaid Programs: Conditions of Participation for Home Health Agencies" published in the Federal Register on January 13, 2017 (82 FR 4504). The published effective date for the final rule was July 13, 2017, and this rule delays the effective date for an additional 6 months until January 13, 2018. This final rule also includes two conforming changes to dates that are included in the regulations text.
771 This final rule updates the Medicaid Eligibility Quality Control (MEQC) and Payment Error Rate Measurement (PERM) programs based on the changes to Medicaid and the Children's Health Insurance Program (CHIP) eligibility under the Patient Protection and Affordable Care Act. This rule also implements various other improvements to the PERM program.
772 The Food and Drug Administration (FDA) is correcting a document that appeared in the Federal Register of Thursday, April 6, 2017 (82 FR 16733). That notification published three waivers from the Requirements of 21 CFR part 1, subpart O--Sanitary Transportation of Human and Animal Food (the Sanitary Transportation rule). That document was published with an error in the Background section. This correction is being made to improve the accuracy of the notification.
773 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the expanded safe use of spirulina extract to seasonally color hard-boiled shell eggs at levels consistent with good manufacturing practice (GMP). This action is in response to a color additive petition (CAP) filed by McCormick & Company, Inc. (McCormick).
774 The Food and Drug Administration (FDA or we) is extending the comment period for the interim final rule that appeared in the Federal Register of May 4, 2017. In the interim final rule, FDA requested comments on the extension of the compliance date for our final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The interim final rule extended the compliance date from May 5, 2017, to May 7, 2018, and invited comment on several specific questions on how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives to provide consumers with nutrition information so that they can make informed choices for themselves and their families. We are taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
775 The Food and Drug Administration (FDA) is amending regulations to reflect changes recently enacted into law by the 21st Century Cures Act. Specifically, certain requirements related to humanitarian device exemptions (HDEs) and institutional review boards (IRBs) for devices have changed. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended.
776 This final rule finalizes May 20, 2017 as the effective date of the final rule titled "Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model (CJR)" originally published in the January 3, 2017 Federal Register. This final rule also finalizes a delay of the applicability date of the regulations at 42 CFR part 512 from July 1, 2017 to January 1, 2018 and delays the effective date of the specific CJR regulations listed in the DATES section from July 1, 2017 to January 1, 2018.
777 In the Federal Register of January 9, 2017, the Food and Drug Administration (FDA or the Agency) issued a final rule entitled "Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses' " (Final Rule). On March 20, 2017, FDA published a document in the Federal Register (Final Rule Extension) to delay the effective date of the Final Rule until March 19, 2018, and requested comments on particular issues raised in a petition for reconsideration and stay of action of the Final Rule. The petition for reconsideration raised questions about the amendments to the regulations regarding "intended uses" that are set forth in the Final Rule. In the Final Rule Extension FDA also requested comments regarding any aspect of the Final Rule, or with respect to issues relating to "intended uses" generally, and on whether the delay in the effective date should be modified or revoked. FDA is now issuing this document to extend the comment period. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
778 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2017. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect several changes of sponsorship of applications and to make correcting amendments to improve the accuracy of the regulations.
779 The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
780 The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. In the Federal Register of December 30, 2016, we stated that the compliance date for the final rule would be May 5, 2017. We are extending the compliance date to May 7, 2018. We are taking this action to enable us to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration's policies.
781 The Food and Drug Administration (FDA or we) is amending the food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers because this use has been abandoned. This action is in response to a petition filed by Keller and Heckman LLP on behalf of the Society of the Plastics Industry, Inc.
782 The Food and Drug Administration (FDA, Agency, or we) is publishing three waivers from the requirements of the Sanitary Transportation of Human and Animal Food (the Sanitary Transportation rule). The Agency is taking this action in accord with the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
783 In the November 14, 2016 issue of the Federal Register (81 FR 79562), we published a final rule with comment period entitled "Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital" that made changes to the demonstration of meaningful use criteria under Sec. 495.40. This correcting amendment corrects a technical error in Sec. 495.40 resulting from an error in that final rule with comment period.
784 This final rule addresses the hospital-specific limitation on Medicaid disproportionate share hospital (DSH) payments under section 1923(g)(1)(A) of the Social Security Act (Act), and the application of such limitation in the annual DSH audits required under section 1923(j) of the Act, by clarifying that the hospital-specific DSH limit is based only on uncompensated care costs. Specifically, this rule makes explicit in the text of the regulation, an existing interpretation that uncompensated care costs include only those costs for Medicaid eligible individuals that remain after accounting for payments made to hospitals by or on behalf of Medicaid eligible individuals, including Medicare and other third party payments that compensate the hospitals for care furnished to such individuals. As a result, the hospital-specific limit calculation will reflect only the costs for Medicaid eligible individuals for which the hospital has not received payment from any source.
785 The Food and Drug Administration (FDA or we) is amending the prior notice of imported food regulations to reflect a change in the electronic data interchange system and its expanded capabilities, to correct inaccurate number designations in section headings, and to reflect a change in an office's name. This action is ministerial or editorial in nature.
786 This document corrects technical errors in the addenda to the final rule published in the November 15, 2016, Federal Register entitled, "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements."
787 This interim final rule with comment period (IFC) further delays the effective date of the final rule entitled "Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model" published in the January 3, 2017 Federal Register (82 FR 180) from March 21, 2017 until May 20, 2017. This IFC also delays the applicability date of the regulations at 42 CFR part 512 from July 1, 2017 to October 1, 2017 and effective date of the specific CJR regulations itemized in the DATES section from July 1, 2017 to October 1, 2017. We seek comment on the appropriateness of this delay, as well as a further applicability date delay until January 1, 2018.
788 The Food and Drug Administration (FDA or we) is further delaying the effective date of a final rule published in the Federal Register of January 9, 2017. In the Federal Register of February 7, 2017, we delayed until March 21, 2017, the effective date of the final rule. This action further delays the effective date of the rule until March 19, 2018. FDA has received a petition from affected parties which raises questions about the amendments to the regulations regarding "intended uses" and requests that FDA reconsider these amendments. FDA is further delaying the effective date to invite public comment on the important substantive issues raised by the petition and to allow additional time to fully evaluate these issues and any other issues raised in response to this request for comments. FDA is seeking input on some specific questions, and is also interested in any other pertinent information or comments stakeholders would like to provide regarding any aspect of the final rule, or with respect to issues relating to "intended uses" generally.
789 The Food and Drug Administration (FDA, the Agency, or we) is making revisions to Chapter I of its regulations. These revisions are necessary to reflect changes to the Agency's organizational structure, including the dissolution of the Regional Food and Drug Director position. The revisions replace references to the Regional Food and Drug Director, who is designated to preside over administrative appeals and at informal hearings on appeal, with references to Office of Regulatory Affairs Program Directors. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
790 The Food and Drug Administration (FDA) is classifying the continuous glucose monitor secondary display into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the continuous glucose monitor secondary display's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
791 The Food and Drug Administration (FDA) is classifying the high throughput genomic sequence analyzer for clinical use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the high throughput genomic sequence analyzer for clinical use device. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
792 The Food and Drug Administration (FDA) is classifying the vibratory counter-stimulation device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the vibratory counter-stimulation device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
793 This document corrects technical errors that appeared in the correcting amendment published in the January 3, 2017 Federal Register (82 FR 37 through 40) entitled, "Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability; Corrections."
794 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect the change of sponsorship of an application and a change of a sponsor's name.
795 The Food and Drug Administration (FDA) is withdrawing approval of a new animal drug application (NADA) and an abbreviated new animal drug application (ANADA) at the sponsors' requests because the products are no longer manufactured or marketed.
796 The Food and Drug Administration (FDA) is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures ("specialized surgical instrumentation for use with urogynecologic surgical mesh"). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh.
797 In accordance with a determination by the Director of the Office of Management and Budget (OMB) that the direct final rule ("Use of Ozone Depleting Substances") published on October 26, 2016, is excluded from the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review," this action confirms the effective date of February 23, 2017, for the direct final rule.
798 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during September and October 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of several applications and a change of a sponsor's address.
799 The Food and Drug Administration (FDA) is withdrawing approval of an abbreviated new animal drug application (ANADA) at the sponsor's request because the product is no longer manufactured or marketed.
800 The Food and Drug Administration (FDA) is withdrawing approval of 18 new animal drug applications (NADAs) and 2 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine's initiative for the Judicious Use of Antimicrobials.
801 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of eight supplemental new animal drug applications (NADAs). The effect of these supplemental applications will be to change the marketing status from over-the- counter (OTC) use to use by veterinary feed directive (VFD) for these antimicrobial drugs of importance to human medicine, administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for production indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and abbreviated new animal drug applications (ANADAs) that were affected by this initiative.
802 In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review", this action delays for 60 days from the date of the memorandum the effective date of the rule entitled "Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model" published in the January 3, 2017 Federal Register (82 FR 180). That rule implements three new Medicare Parts A and B episode payment models and a Cardiac Rehabilitation (CR) Incentive Payment model, and implements changes to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social Security Act (the Act). Under the three new episode payment models, acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee-for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. Under the CR Incentive Payment model, acute care hospitals in certain selected geographic areas will receive retrospective incentive payments for beneficiary utilization of cardiac rehabilitation/intensive cardiac rehabilitation services during the 90 days following discharge from a hospitalization treatment of an acute myocardial infarction or coronary artery bypass graft surgery. We believe these models will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures.
803 In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review," this action delays the effective date of the final rule ("Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding `Intended Uses' "), which published on January 9, 2017, from February 8, 2017, until March 21, 2017.
804 In accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review," this action revises the effective date of the final rule ("Refuse to Accept Procedures for Premarket Tobacco Product Submissions") published December 29, 2016, from January 30, 2017, until March 21, 2017.
805 The Food and Drug Administration (FDA or we) is confirming the effective date of December 2, 2016, for the final rule that appeared in the Federal Register of November 1, 2016, and that amended the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses (IOLs). We are taking this action to ensure clarity that the effective date in the final rule remains December 2, 2016.
806 This rule finalizes changes to the pass-through payment transition periods and the maximum amount of pass-through payments permitted annually during the transition periods under Medicaid managed care contract(s) and rate certification(s). This final rule prevents increases in pass-through payments and the addition of new pass-through payments beyond those in place when the pass-through payment transition periods were established, in the final Medicaid managed care regulations effective July 5, 2016.
807 This final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, this final rule revises procedures that the Department of Health and Human Services follows at the Centers for Medicare & Medicaid Services (CMS) and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the ALJ level.
808
809 This final rule revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad- based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.
810 The Food and Drug Administration (FDA) is reclassifying antigen based rapid influenza virus antigen detection test systems intended to detect influenza virus directly from clinical specimens that are currently regulated as influenza virus serological reagents from class I into class II with special controls and into a new device classification regulation.
811
812 The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
813 The Food and Drug Administration (FDA or the Agency) is reclassifying surgical instrumentation for use with urogynecologic surgical mesh from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and identifying them as "specialized surgical instrumentation for use with urogynecologic surgical mesh." FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.
814 This document corrects technical errors that appeared in the final rule published in the May 6, 2016 Federal Register (81 FR 27498 through 27901) entitled, "Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability." The effective date for the rule was July 5, 2016.
815 This document corrects technical errors that appeared in the final rule with comment period and interim final rule with comment period published in the Federal Register on November 14, 2016, entitled "Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Procurement Organization Reporting and Communication; Transplant Outcome Measures and Documentation Requirements; Electronic Health Record (EHR) Incentive Programs; Payment to Nonexcepted Off-Campus Provider-Based Department of a Hospital; Hospital Value-Based Purchasing (VBP) Program; Establishment of Payment Rates under the Medicare Physician Fee Schedule for Nonexcepted Items and Services Furnished by an Off-Campus Provider-Based Department of a Hospital." This document extends the comment period to January 3, 2017 for both the final rule with comment period and the interim final rule with comment period.
816 This final rule implements three new Medicare Parts A and B episode payment models, a Cardiac Rehabilitation (CR) Incentive Payment model and modifications to the existing Comprehensive Care for Joint Replacement model under section 1115A of the Social Security Act. Acute care hospitals in certain selected geographic areas will participate in retrospective episode payment models targeting care for Medicare fee- for-service beneficiaries receiving services during acute myocardial infarction, coronary artery bypass graft, and surgical hip/femur fracture treatment episodes. All related care within 90 days of hospital discharge will be included in the episode of care. We believe these models will further our goals of improving the efficiency and quality of care for Medicare beneficiaries receiving care for these common clinical conditions and procedures.
817 The Food and Drug Administration (FDA) is issuing a final order to reclassify pedicle screw systems, a preamendments class III device (regulated under product code NKB), into class II (special controls), renaming the device "thoracolumbosacral pedicle screw systems"; reclassify dynamic stabilization systems, a subtype of pedicle screw systems regulated under product code NQP when used as an adjunct to fusion, into class II (special controls), renaming this device subtype "semi-rigid systems"; and clarify the device identification of pedicle screw systems to more clearly delineate between rigid pedicle screw systems and semi-rigid systems. FDA is finalizing this action based on a reevaluation of information pertaining to the device type.
818 The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the Federal Register of December 1, 2014, and on May 5, 2016, we stated in the Federal Register that the enforcement of the final rule would begin on May 5, 2017. We are taking this action to clarify and confirm that the compliance date for the final rule is May 5, 2017.
819 The Food and Drug Administration (FDA) is issuing a final rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the rule, FDA will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the proposed rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions.
820 This document corrects technical and typographical errors that appeared in the final rule published in the November 15, 2016 Federal Register (81 FR 80170). That rule is entitled, "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements."
821 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 43 supplemental new animal drug applications (NADAs) and 52 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) to prescription (Rx) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated drinking water. These applications were submitted in voluntary compliance with the goals of the FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative.
822 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of 71 supplemental new animal drug applications (NADAs) and 35 supplemental abbreviated new animal drug applications (ANADAs) for revised labeling reflecting a change in marketing status from over-the-counter (OTC) use to use by veterinary feed directive (VFD) for antimicrobial drugs of importance to human medicine administered to food-producing animals in medicated feed. Where applicable, FDA is also withdrawing approval of those parts of the NADAs that pertain to use of these antimicrobial drugs for growth promotion indications. These actions are being taken at the sponsors' requests because these particular medicated feeds will no longer be manufactured or marketed. These applications were submitted in voluntary compliance with the goals of FDA Center for Veterinary Medicine's (CVM's) Judicious Use Initiative. In addition, the animal drug regulations are being amended to reflect the voluntary withdrawal of approval of certain entire NADAs and ANADAs that were affected by this initiative. The animal drug regulations are also being amended to reflect several non-substantive changes in format. These technical amendments are being made to improve the consistency and readability of the regulations.
823 The Food and Drug Administration (FDA) is withdrawing approval of 11 new animal drug applications (NADAs) and 4 abbreviated new animal drug applications (ANADAs). These withdrawals of approval of NADAs and ANADAs for antimicrobial drugs of importance to human medicine that are administered to food-producing animals in medicated feed are being made because the products are no longer being manufactured or marketed. These actions are consistent with the FDA Center for Veterinary Medicine's initiative for the Judicious Use of Antimicrobials.
824 The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete poultry feeds. This action is in response to a food additive petition filed by BASF Corp.
825 The Food and Drug Administration (FDA) is classifying the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the neurovascular mechanical thrombectomy device for acute ischemic stroke treatment's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
826 This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on November 4, 2016, entitled "Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model."
827 This document announces the implementation of the prior authorization program for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) items in two phases and the issuance of the initial Required Prior Authorization List of DMEPOS items that require prior authorization as a condition of payment.
828 The Food and Drug Administration (FDA or Agency) is issuing regulations to set forth postmarketing safety reporting requirements for combination products. Specifically, this final rule describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as "constituent parts" of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization. The rule is intended to promote and protect the public health by setting forth the requirements for postmarketing safety reporting for these combination products, and is part of FDA's ongoing effort to ensure the consistency and appropriateness of the regulatory requirements for combination products.
829 This rule is intended to carry out the President's directives in Executive Order 13563: Improving Regulation and Regulatory Review. The final rule will make Child Support Enforcement program operations and enforcement procedures more flexible, more effective, and more efficient by recognizing the strength of existing State enforcement programs, advancements in technology that can enable improved collection rates, and the move toward electronic communication and document management. This final rule will improve and simplify program operations, and remove outmoded limitations to program innovations to better serve families. In addition, the final rule clarifies and corrects technical provisions in existing regulations. The rule makes significant changes to the regulations on case closure, child support guidelines, and medical support enforcement. It will improve child support collection rates because support orders will reflect the noncustodial parent's ability to pay support, and more noncustodial parents will support their children.
830 The Food and Drug Administration (FDA) is issuing a final rule to rename pediatric hospital beds as pediatric medical cribs and establish special controls for these devices. FDA is also establishing a separate classification regulation for medical bassinets, previously under the pediatric hospital bed classification regulation, as a class II (special controls) device. In addition, this rule continues to allow both devices to be exempt from premarket notification and use of the device in traditional health care settings and permits prescription use of pediatric medical cribs and bassinets outside of traditional health care settings.
831 The Food and Drug Administration (FDA or we) is amending the regulation authorizing a health claim on the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease (CHD) to permit raw fruits and vegetables that fail to comply with the "low fat" definition and/or the minimum nutrient content requirement to be eligible to bear the claim. We are taking this action in response to a petition submitted by the American Heart Association (the petitioner). The amendment expands the use of this health claim to certain fruits and vegetables that are currently ineligible for the health claim.
832 The Food and Drug Administration (FDA or Agency) has determined that Powdered Surgeon's Gloves, Powdered Patient Examination Gloves, and Absorbable Powder for Lubricating a Surgeon's Glove present an unreasonable and substantial risk of illness or injury and that the risk cannot be corrected or eliminated by labeling or a change in labeling. Consequently, FDA is banning these devices.
833 The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work FDA performs to establish and administer the third-party certification program under the FDA Food Safety Modernization Act (FSMA).
834 This interim final rule with comment period implements new requirements for Medicare-certified dialysis facilities that make payments of premiums for individual market health plans. These requirements apply to dialysis facilities that make such payments directly, through a parent organization, or through a third party. These requirements are intended to protect patient health and safety; improve patient disclosure and transparency; ensure that health insurance coverage decisions are not inappropriately influenced by the financial interests of dialysis facilities rather than the health and financial interests of patients; and protect patients from mid-year interruptions in coverage.
835 The Food and Drug Administration (FDA) is correcting a final rule entitled "Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs" that appeared in the Federal Register of August 31, 2016 (81 FR 60169). That final rule amended current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule was published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. This document corrects that error.
836 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry and FDA staff entitled "Third- Party Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards." The guidance contains FDA recommendations on third-party certification body qualifications for accreditation to conduct food safety audits and to issue food and/or facility certifications under an FDA program required by the FDA Food Safety Modernization Act (FSMA). The guidance is intended to describe the standards for accreditation of third-party certification bodies as required under the final rule entitled "Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications." In addition, this guidance discusses specific clauses of ISO/IEC 17021: 2015 and industry practice that are currently being used by third-party certification bodies and that FDA recommends accreditation bodies consider as a model when making accreditation decisions.
837 The Food and Drug Administration (FDA) is classifying the Computerized Cognitive Assessment Aid for Concussion into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the computerized cognitive assessment aid for concussion's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
838 The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds. This action is in response to a food additive petition filed by Alzchem AG.
839 This final rule implements provisions of the Affordable Care Act that expand access to health coverage through improvements in Medicaid and coordination between Medicaid, CHIP, and Exchanges. This rule finalizes most of the remaining provisions from the "Medicaid, Children's Health Insurance Programs, and Exchanges: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes for Medicaid and Exchange Eligibility Appeals and Other Provisions Related to Eligibility and Enrollment for Exchanges, Medicaid and CHIP, and Medicaid Premiums and Cost Sharing; Proposed Rule" that we published in the January 22, 2013, Federal Register. This final rule continues our efforts to assist states in implementing Medicaid and CHIP eligibility, appeals, and enrollment changes required by the Affordable Care Act.
840 The Food and Drug Administration (FDA) is confirming the effective date of December 1, 2016, for the final rule that appeared in the Federal Register of August 24, 2016. The direct final rule amends the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This document confirms the effective date of the direct final rule.
841 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.
842 The Food and Drug Administration (FDA or we) is establishing January 1, 2020, as the uniform compliance date for food labeling regulations that are issued between January 1, 2017, and December 31, 2018. We periodically announce uniform compliance dates for new food labeling requirements to minimize the economic impact of label changes.
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846 The Food and Drug Administration (FDA or Agency) is amending its nonprescription (over-the-counter or OTC) drug regulations. This final rule supplements the time and extent application (TEA) process for OTC drugs by establishing timelines and performance metrics for FDA's review of non-sunscreen TEAs, as required by the Sunscreen Innovation Act (SIA). It also amends the existing TEA process to include filing determination and withdrawal provisions to make the TEA process more efficient.
847 The Food and Drug Administration (FDA or we) is amending the food additive regulations to no longer provide for the use of two specific perfluoroalkyl containing substances as oil and water repellents for paper and paperboard for use in contact with aqueous and fatty foods because these uses have been abandoned. This action is in response to a petition filed by Keller and Heckman LLP on behalf of 3M Corporation.
848 The Food and Drug Administration (FDA or the Agency) is amending its current good manufacturing practice (CGMP) and labeling regulations regarding medical gases. FDA is requiring that portable cryogenic medical gas containers not manufactured with permanent gas use outlet connections have gas-specific use outlet connections that cannot be readily removed or replaced except by the manufacturer. FDA is also requiring that portable cryogenic medical gas containers and high-pressure medical gas cylinders meet certain labeling, naming, and color requirements. These requirements are intended to increase the likelihood that the contents of medical gas containers are accurately identified and reduce the likelihood of the wrong gas being connected to a gas supply system or container. FDA is also revising an existing regulation that conditionally exempts certain medical gases from certain otherwise-applicable labeling requirements in order to add oxygen and nitrogen to the list of gases subject to the exemption, and to remove cyclopropane and ethylene from the list.
849 This document corrects technical errors in the final rule that was placed on public inspection at the Office of the Federal Register on November 2, 2016 and scheduled for publication in the Federal Register on November 15, 2016. That rule is entitled, "Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements."
850 The Food and Drug Administration (FDA) published in the Federal Register of August 8, 2016, a direct final rule regarding procedures for refusing to accept premarket tobacco product submissions. The comment period closed October 24, 2016. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. FDA will consider the comments we received on the direct final rule to be comments on the companion proposed rule published at 81 FR 52371 (August 8, 2016).
851 This document corrects typographical errors that appeared in the final rule published in the Federal Register on September 16, 2016 entitled "Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers."
852 The Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment, we amended the regulatory definitions of "States" and "United States" to include the U.S. territories (American Samoa, the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the Virgin Islands) beginning April 1, 2017. This interim final rule with comment period delays the inclusion of the territories in the definition of "States" and "United States" until April 1, 2020.
853 This major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also includes changes related to the Medicare Shared Savings Program, requirements for Medicare Advantage Provider Networks, and provides for the release of certain pricing data from Medicare Advantage bids and of data from medical loss ratio reports submitted by Medicare health and drug plans. In addition, this final rule expands the Medicare Diabetes Prevention Program model.
854 This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2017 to implement applicable statutory requirements and changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. Further, in this final rule with comment period, we are making changes to tolerance thresholds for clinical outcomes for solid organ transplant programs; to Organ Procurement Organizations (OPOs) definitions, outcome measures, and organ transport documentation; and to the Medicare and Medicaid Electronic Health Record Incentive Programs. We also are removing the HCAHPS Pain Management dimension from the Hospital Value-Based Purchasing (VBP) Program. In addition, we are implementing section 603 of the Bipartisan Budget Act of 2015 relating to payment for certain items and services furnished by certain off-campus provider-based departments of a provider. In this document, we also are issuing an interim final rule with comment period to establish the Medicare Physician Fee Schedule payment rates for the nonexcepted items and services billed by a nonexcepted off-campus provider-based department of a hospital in accordance with the provisions of section 603.
855 The Food and Drug Administration (FDA, the Agency, or we) is amending certain regulations relating to citizen petitions, petitions for stay of action (PSAs), and the submission of documents to the Agency. In particular, the final rule establishes new regulations to implement certain provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which concern certain citizen petitions and PSAs that involve a request for FDA to take any form of action relating to a pending abbreviated new drug application (ANDA), 505(b)(2) application, or certain applications submitted under the Public Health Service Act (PHS Act). We are making these changes to implement provisions of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the Food and Drug Administration Safety and Innovation Act (FDASIA).
856 The Food and Drug Administration (FDA) is issuing this final rule to amend the regulations to reflect organization change in the Agency and to make other conforming changes. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
857 The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) repeals the Medicare sustainable growth rate (SGR) methodology for updates to the physician fee schedule (PFS) and replaces it with a new approach to payment called the Quality Payment Program that rewards the delivery of high-quality patient care through two avenues: Advanced Alternative Payment Models (Advanced APMs) and the Merit-based Incentive Payment System (MIPS) for eligible clinicians or groups under the PFS. This final rule with comment period establishes incentives for participation in certain alternative payment models (APMs) and includes the criteria for use by the Physician-Focused Payment Model Technical Advisory Committee (PTAC) in making comments and recommendations on physician-focused payment models (PFPMs). Alternative Payment Models are payment approaches, developed in partnership with the clinician community, that provide added incentives to deliver high-quality and cost-efficient care. APMs can apply to a specific clinical condition, a care episode, or a population. This final rule with comment period also establishes the MIPS, a new program for certain Medicare-enrolled practitioners. MIPS will consolidate components of three existing programs, the Physician Quality Reporting System (PQRS), the Physician Value-based Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) Incentive Program for Eligible Professionals (EPs), and will continue the focus on quality, cost, and use of certified EHR technology (CEHRT) in a cohesive program that avoids redundancies. In this final rule with comment period we have rebranded key terminology based on feedback from stakeholders, with the goal of selecting terms that will be more easily identified and understood by our stakeholders.
858 This rule updates and makes revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017. It also finalizes policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also sets forth requirements for the ESRD Quality Incentive Program, including the inclusion of new quality measures beginning with payment year (PY) 2020 and provides updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also implements statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also expands suppliers' appeal rights in the event of a breach of contract action taken by CMS, by revising the appeals regulation to extend the appeals process to all types of actions taken by CMS for a supplier's breach of contract, rather than limit an appeal for the termination of a competitive bidding contract. The rule also finalizes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from CBPs and for submitting bids and establishing single payment amounts under the CBPs for certain groupings of similar items with different features to address price inversions. Final changes also are made to the method for establishing bid limits for items under the DMEPOS CBPs. In addition, this rule summarizes comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule also summarizes comments received in response to a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.
859 This final rule updates the Home Health Prospective Payment System (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor; effective for home health episodes of care ending on or after January 1, 2017. This rule also: Implements the last year of the 4-year phase-in of the rebasing adjustments to the HH PPS payment rates; updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the 2nd-year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between CY 2012 and CY 2014; finalizes changes to the methodology used to calculate payments made under the HH PPS for high-cost "outlier" episodes of care; implements changes in payment for furnishing Negative Pressure Wound Therapy (NPWT) using a disposable device for patients under a home health plan of care; discusses our efforts to monitor the potential impacts of the rebasing adjustments; includes an update on subsequent research and analysis as a result of the findings from the home health study; and finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model, which was implemented on January 1, 2016; and updates to the Home Health Quality Reporting Program (HH QRP).
860 The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of titanium dioxide and [phthalocyaninato (2-)] copper to color orientation marks for intraocular lenses. This action is in response to a petition filed by Milton W. Chu, M.D.
861 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food"--Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food."
862 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry #241 entitled "What You Need To Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals"--Small Entity Compliance Guide. The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals."
863 This document corrects a typographical error in the final rule that appeared in the August 22, 2016 Federal Register as well as additional typographical errors in a related correction to that rule that appeared in the October 5, 2016 Federal Register. The final rule was titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals".
864 The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as "essential uses" under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is taking this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs.
865 The Food and Drug Administration (FDA) is classifying the Eustachian tube balloon dilation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the Eustachian tube balloon dilation system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
866 The Food and Drug Administration (FDA) is classifying the Upper Extremity Prosthesis Including a Simultaneously Powered Elbow and/or Shoulder with Greater Than Two Simultaneous Powered Degrees of Freedom and Controlled by Non-Implanted Electrical Components into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the upper extremity prosthesis including a simultaneously powered elbow and/or shoulder with greater than two simultaneous powered degrees of freedom and controlled by non-implanted electrical components' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
867 The Food and Drug Administration (FDA) is classifying the apical closure device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the apical closure device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
868 This document corrects a technical error that appeared in the document published in the Federal Register on January 22, 2016 entitled "Medicare Program; Explanation of FY 2004 Outlier Fixed-Loss Threshold as Required by Court Rulings."
869 The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This new provision, under FDASIA, amends the existing custom device exemption and introduces new concepts and procedures applicable to custom devices. This action is being taken to align the regulations with the FD&C Act.
870 The Food and Drug Administration (FDA or the Agency) is amending its regulations to revise the list of drug products that have been withdrawn or removed from the market because the drug products or components of such drug products have been found to be unsafe or not effective. Drugs appearing on this list may not be compounded under the exemptions provided by sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). Specifically, the rule adds 24 entries to this list of drug products, modifies the description of one entry on this list, and revises the list's title and introductory language. These revisions are necessary because information has come to the Agency's attention since March 8, 1999, when FDA published the original list as a final rule.
871 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.
872 This document corrects technical and typographical errors in the final rule that appeared in the August 22, 2016 Federal Register titled "Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2017 Rates; Quality Reporting Requirements for Specific Providers; Graduate Medical Education; Hospital Notification Procedures Applicable to Beneficiaries Receiving Observation Services; Technical Changes Relating to Costs to Organizations and Medicare Cost Reports; Finalization of Interim Final Rules With Comment Period on LTCH PPS Payments for Severe Wounds, Modifications of Limitations on Redesignation by the Medicare Geographic Classification Review Board, and Extensions of Payments to MDHs and Low-Volume Hospitals."
873 The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for "method, metallic reduction, glucose (urinary, nonquantitative)" devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as "copper reduction tablet test"). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
874 The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for method, metallic reduction, glucose (urinary, nonquantitative) devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as "copper reduction tablet test"). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
875 This final rule will revise the requirements that Long-Term Care facilities must meet to participate in the Medicare and Medicaid programs. These changes are necessary to reflect the substantial advances that have been made over the past several years in the theory and practice of service delivery and safety. These revisions are also an integral part of our efforts to achieve broad-based improvements both in the quality of health care furnished through federal programs, and in patient safety, while at the same time reducing procedural burdens on providers.
876 The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during July and August 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect a change of a sponsor's address.
877 The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of feed grade sodium formate as a feed acidifying agent in complete swine feeds. This action is in response to a food additive petition filed by BASF Corp.
878 The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
879 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Use of the Term `Healthy' in the Labeling of Human Food Products: Guidance for Industry." The guidance advises manufacturers who wish to use the implied nutrient content claim "healthy" to label their food products as provided by our regulations. More specifically, the guidance advises food manufacturers of our intent to exercise enforcement discretion with respect to the implied nutrient content claim "healthy" on foods that have a fat profile of predominantly mono and polyunsaturated fats, but do not meet the regulatory definition of "low fat", or that contain at least 10 percent of the Daily Value (DV) per reference amount customarily consumed (RACC) of potassium or vitamin D.
880 The Food and Drug Administration (FDA) is classifying the strabismus detection device into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the strabismus detection device's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
881 The Food and Drug Administration (FDA) is classifying the Magnetic Surgical Instrument System into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the magnetic surgical instrument system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
882 The Food and Drug Administration (FDA or we) is announcing the effective date for the definition of qualified auditor in the two final rules that appeared in the Federal Register of September 17, 2015.
883 This final rule establishes national emergency preparedness requirements for Medicare- and Medicaid-participating providers and suppliers to plan adequately for both natural and man-made disasters, and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. It will also assist providers and suppliers to adequately prepare to meet the needs of patients, residents, clients, and participants during disasters and emergency situations. Despite some variations, our regulations will provide consistent emergency preparedness requirements, enhance patient safety during emergencies for persons served by Medicare- and Medicaid- participating facilities, and establish a more coordinated and defined response to natural and man-made disasters.
884 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the withdrawal of approval of those parts of a new animal drug application (NADA) for a 3-way, fixed-ratio, combination drug Type A medicated article that pertain to use of the procaine penicillin component for production indications in swine and to reflect the reformulation of the Type A medicated article as a 2- way, fixed-ratio, combination drug product without penicillin.
885 The Food and Drug Administration (FDA or we) is amending its regulations to remove the maximum civil money penalties table associated with statutory provisions. This information will be included in the Department of Health and Human Services' (HHS) regulations. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 2015.
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887 The Department of Health and Human Services (HHS) is issuing a new regulation to adjust for inflation the maximum civil monetary penalty amounts for the various civil monetary penalty authorities for all agencies within HHS. We are taking this action to comply with the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. In addition, this interim final rule includes updates to certain agency-specific regulations to identify their updated information, and note the location of HHS-wide regulations.
888 The Food and Drug Administration (FDA, we, or the Agency) is issuing this final rule establishing that certain active ingredients used in over-the-counter (OTC) consumer antiseptic products intended for use with water (referred to throughout this document as consumer antiseptic washes) are not generally recognized as safe and effective (GRAS/GRAE) and are misbranded. FDA is issuing this final rule after considering the recommendations of the Nonprescription Drugs Advisory Committee (NDAC); public comments on the Agency's notices of proposed rulemaking; and all data and information on OTC consumer antiseptic wash products that have come to the Agency's attention. This final rule amends the 1994 tentative final monograph (TFM) for OTC antiseptic drug products that published in the Federal Register of June 17, 1994 (the 1994 TFM). The final rule is part of the ongoing review of OTC drug products conducted by FDA.
889 This document corrects typographical errors in the final rule that appeared in the August 5, 2016 Federal Register entitled, "Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2017".
890 The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.
891 The Food and Drug Administration (FDA or we) is amending the food labeling regulations by redesignating a provision, updating any references to that provision to reflect the redesignation, and revising the section heading. The rule does not alter the content or application of the redesignated provision in any substantive manner. This action is editorial in nature and is intended to provide clarity and consistency to our regulations.
892 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during May and June 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications, changes of sponsors' names and addresses, and the voluntary withdrawals of approval of applications.
893 The Food and Drug Administration (FDA) is withdrawing approval of eight new animal drug applications (NADAs) at the sponsor's request because these products are no longer manufactured or marketed.
894 The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
895 The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.
896 We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2017. Some of these changes will implement certain statutory provisions contained in the Pathway for Sustainable Growth Reform Act of 2013, the Improving Medicare Post- Acute Care Transformation Act of 2014, the Notice of Observation Treatment and Implications for Care Eligibility Act of 2015, and other legislation. We also are providing the estimated market basket update to apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits for FY 2017. We are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2017. In addition, we are making changes relating to direct graduate medical education (GME) and indirect medical education payments; establishing new requirements or revising existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, LTCHs, and inpatient psychiatric facilities), including related provisions for eligible hospitals and critical access hospitals (CAHs) participating in the Electronic Health Record Incentive Program; updating policies relating to the Hospital Value-Based Purchasing Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition Reduction Program; implementing statutory provisions that require hospitals and CAHs to furnish notification to Medicare beneficiaries, including Medicare Advantage enrollees, when the beneficiaries receive outpatient observation services for more than 24 hours; announcing the implementation of the Frontier Community Health Integration Project Demonstration; and making technical corrections and changes to regulations relating to costs to related organizations and Medicare cost reports; we are providing notice of the closure of three teaching hospitals and the opportunity to apply for available GME resident slots under section 5506 of the Affordable Care Act. We are finalizing the provisions of interim final rules with comment period that relate to a temporary exception for certain wound care discharges from the application of the site neutral payment rate under the LTCH PPS for certain LTCHs; application of two judicial decisions relating to modifications of limitations on redesignation by the Medicare Geographic Classification Review Board; and legislative extensions of the Medicare-dependent, small rural hospital program and changes to the payment adjustment for low-volume hospitals.
897 The Food and Drug Administration (FDA or we) is issuing a final rule that amends and clarifies the criteria in our regulations for when the use of a substance in food for humans or animals is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) because the substance is generally recognized as safe (GRAS) under the conditions of its intended use. We also are amending our regulations to replace the voluntary GRAS affirmation petition process with a voluntary notification procedure under which any person may notify us of a conclusion that a substance is GRAS under the conditions of its intended use. The clarified criteria for GRAS status should help stakeholders draw more informed conclusions about whether the intended conditions of use of a substance in food for humans or animals complies with the FD&C Act, and the notification procedure will enable stakeholders to be aware of whether we have questioned the basis of a conclusion of GRAS status.
898 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Calorie Labeling of Articles of Food in Vending Machines--Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule entitled "Food Labeling; Calorie Labeling of Articles of Food in Vending Machines."
899 The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry, entitled "Calorie Labeling of Articles of Food in Vending Machines." The draft guidance, when finalized, will help covered vending machine operators and industry to better understand and comply with the final rule entitled "Food Labeling: Calorie Labeling of Articles of Food in Vending Machines."
900 The Food and Drug Administration (FDA) is amending its regulations to correct an error in the lists of statutory and regulatory provisions that provide an opportunity for an informal hearing so that the lists correctly reference the statutory and regulatory provisions that provide such an opportunity in connection with a ban of a device. This action is being taken to align the regulations with the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and avoid any potential confusion the erroneous lists may cause.
901 The Food and Drug Administration (FDA, the Agency, or we) is making technical corrections to its regulations for hearing procedures for denial of approval or withdrawal of approval of new animal drug applications. The Agency is taking this action to harmonize terminology and to improve the organization and clarity of the regulations.
902 The Food and Drug Administration (FDA) is confirming the effective date of September 16, 2016, for the final rule that appeared in the Federal Register of May 4, 2016. The direct final rule amends the general biological products standards relating to dating periods and removes certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities without diminishing public health concerns. This action is part of FDA's retrospective review of its regulations in response to an Executive order. This document confirms the effective date of the direct final rule.
903 The Food and Drug Administration (FDA) is issuing a rule describing when FDA will refuse to accept a tobacco product submission (or application) because the application has not met a minimum threshold for acceptability for FDA review. Under the rule, FDA will refuse to accept a tobacco product submission, for example, that is not in English, does not pertain to a tobacco product, or does not identify the type of submission. By refusing to accept submissions that have the deficiencies identified in the rule, FDA will be able to focus our review resources on submissions that meet a threshold of acceptability and encourage quality submissions. FDA is issuing this action directly as a final rule because we believe there is little likelihood that we will receive any significant adverse comments opposing the rule given the specific deficiencies identified that will result in FDA's refusal to accept the submission.
904 This final rule updates the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2017. In addition, it specifies a potentially preventable readmission measure for the Skilled Nursing Facility Value- Based Purchasing Program (SNF VBP), and implements requirements for that program, including performance standards, a scoring methodology, and a review and correction process for performance information to be made public, aimed at implementing value-based purchasing for SNFs. Additionally, this final rule includes additional polices and measures in the Skilled Nursing Facility Quality Reporting Program (SNF QRP). This final rule also responds to comments on the SNF Payment Models Research (PMR) project.
905 This final rule will update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2017 as required by the statute. As required by section 1886(j)(5) of the Act, this rule includes the classification and weighting factors for the IRF prospective payment system's (IRF PPS's) case-mix groups and a description of the methodologies and data used in computing the prospective payment rates for FY 2017. This final rule also revises and updates quality measures and reporting requirements under the IRF quality reporting program (QRP).
906 This final rule will update the hospice wage index, payment rates, and cap amount for fiscal year (FY) 2017. In addition, this rule changes the hospice quality reporting program, including adopting new quality measures. Finally, this final rule includes information regarding the Medicare Care Choices Model (MCCM).
907 This notice announces the Provider Enrollment Moratoria Access Waiver Demonstration of Part B Non-Emergency Ground Ambulance Suppliers and Home Health Agencies in 6 states. The demonstration is being implemented in accordance with section 402 of the Social Security Amendments of 1967 and gives CMS the authority to grant waivers to the statewide enrollment moratoria on a case-by-case basis in response to access to care issues, and to subject providers and suppliers enrolling via such waivers to heightened screening, oversight, and investigations.
908 This document announces the extension of temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers and Medicare home health agencies (HHAs), subunits, and branch locations in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey to prevent and combat fraud, waste, and abuse. It also announces the implementation of temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers and Medicare HHAs, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey on a statewide basis. In addition, it announces the lifting of the moratoria on all Part B emergency ground ambulance suppliers. These moratoria, and the changes described in this document, also apply to the enrollment of HHAs and non- emergency ground ambulance suppliers in Medicaid and the Children's Health Insurance Program.
909 The Food and Drug Administration (FDA or we) is extending the compliance date for certain requirements in the final rule requiring disclosure of calorie declarations for food sold from certain vending machines. The final rule appeared in the Federal Register of December 1, 2014. We are taking this action in response to requests for an extension and for reconsideration of the rule's requirements pertaining to the size of calorie disclosures on front-of-package labeling.
910 The Food and Drug Administration (FDA or we) is amending our regulations to reflect a change in the address for the Center for Food Safety and Applied Nutrition (CFSAN). This action is editorial in nature and is intended to improve the accuracy of our regulations.
911 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for 57 approved new animal drug applications (NADAs) and 14 approved abbreviated new animal drug applications (ANADAs) from Elanco Animal Health, A Division of Eli Lilly & Co. to Elanco US, Inc.
912 The Food and Drug Administration (FDA) is issuing a final order to reclassify iontophoresis devices intended for any other purposes, which are preamendments class III devices (regulated under product code EGJ), into class II (special controls) and to amend the device identification to clarify that devices intended to deliver specific drugs are not considered part of this regulatory classification.
913 The Food and Drug Administration (FDA) is confirming the effective date of August 17, 2016, for the direct final rule that appeared in the Federal Register of April 4, 2016. The direct final rule amends the regulations describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with applicable regulations. We are taking this action to ensure clarity and improve the accuracy of the regulations. This document confirms the effective date of the direct final rule.
914 This document corrects a technical error that appeared in the final rule published in the May 6, 2016 Federal Register (81 FR 27498 through 27901) entitled, "Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party Liability." The effective date for the rule was July 5, 2016.
915 The Food and Drug Administration (FDA or we) is amending certain regulations pertaining to registration and process filings related to acidified foods and thermally processed low-acid foods packaged in hermetically sealed containers (historically referred to as "low-acid canned foods" or "LACF"). The amendments reflect new FDA process filing form numbers, make changes to addresses or locations where such forms can be found or must be sent, remove obsolete references to the effective dates that occurred years ago, and update a reference to another Federal Agency.
916 The Food and Drug Administration (FDA or we) is amending the food additive regulations to expand the safe uses of vitamin D<INF>2</INF> as a nutrient supplement in edible plant-based beverages intended for use as milk alternatives and in edible plant-based yogurt alternatives and vitamin D<INF>3</INF> as a nutrient supplement in milk at levels higher than those currently permitted. We are taking this action in response to a food additive petition filed by Dean Foods Company and WhiteWave Foods Company.
917 The Food and Drug Administration (FDA or Agency) is amending the Agency's regulations by removing certain regulations that include obsolete references. FDA is taking this action to improve the accuracy of the regulations.
918 The Food and Drug Administration (FDA or we) is amending its regulations for registration of food facilities that require domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with FDA. This rule amends and updates FDA's registration regulations and is part of our implementation of the FDA Food Safety Modernization Act (FSMA), which added new provisions for the registration of food facilities. These amendments will further enhance FDA's capabilities with respect to responding to food safety issues, and in addition, provide FDA with information that we can use to focus and better utilize our limited inspection resources.
919 The Food and Drug Administration (FDA) is classifying the metallic biliary stent system for benign strictures into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the metallic biliary stent system for benign strictures' classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
920 The Food and Drug Administration (FDA) is classifying the thermal system for insomnia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the thermal system for insomnia's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
921 This final rule implements requirements under Section 105 of the Medicare Access and CHIP Reauthorization Act of 2015 that expand how qualified entities may use and disclose data under the qualified entity program to the extent consistent with applicable program requirements and other applicable laws, including information, privacy, security and disclosure laws. This rule also explains how qualified entities may create non-public analyses and provide or sell such analyses to authorized users, as well as how qualified entities may provide or sell combined data, or provide Medicare claims data alone at no cost, to certain authorized users. In addition, this rule implements certain privacy and security requirements, and imposes assessments on qualified entities if the qualified entity or the authorized user violates the terms of a data use agreement required by the qualified entity program.
922 The Food and Drug Administration (FDA, we, or the Agency) is announcing the availability of a guidance for industry entitled "FDA's Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels: Guidance for Industry." The guidance explains to manufacturers of conventional foods and dietary supplements our policy on determining the amount to declare on the nutrition label for certain nutrients and dietary ingredients that are present in a small amount.
923 This document corrects technical errors that appeared in the final rule published in the Federal Register on May 4, 2016, entitled "Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities."
924 The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
925 The Food and Drug Administration (FDA or we) is extending the comment period for the final rule, published in the Federal Register of June 3, 2016, amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in broiler chicken feed. This action is in response to a food additive petition filed by Kemin Industries, Inc. We are taking this action due to maintenance on the Federal eRulemaking portal from July 1 through July 5, 2016.
926 This final rule implements requirements of section 216 of the Protecting Access to Medicare Act of 2014 (PAMA), which significantly revises the Medicare payment system for clinical diagnostic laboratory tests. This final rule also announces an implementation date of January 1, 2018 for the private payor rate-based fee schedule required by PAMA.
927 The Food and Drug Administration (FDA or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.
928 The Food and Drug Administration (FDA) is classifying the gynecologic laparoscopic power morcellation containment system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the gynecologic laparoscopic power morcellation containment system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
929 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled "Prior Notice of Imported Food Questions and Answers (Edition 3): Guidance for Industry." The guidance provides updated information pertaining to prior notice of imported food under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food Safety Modernization Act (FSMA) on January 4, 2011. The guidance is intended to help the food industry and others comply with prior notice requirements.
930 The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, in labeling (including labels) without adjacent explanatory text (referred to in this document as "stand-alone symbols") if certain requirements are met. The final rule also specifies that the use of symbols, accompanied by adjacent explanatory text continues to be permitted. FDA is also revising its prescription device labeling regulations to allow the use of the symbol statement "Rx only" or "[rx] only" in the labeling for prescription devices.
931 The Food and Drug Administration (FDA) is classifying the nasolacrimal compression device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
932 The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." The guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
933 The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." The guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
934 Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. This final rule addresses changes to the Shared Savings Program, including: Modifications to the program's benchmarking methodology, when resetting (rebasing) the ACO's benchmark for a second or subsequent agreement period, to encourage ACOs' continued investment in care coordination and quality improvement; an alternative participation option to encourage ACOs to enter performance-based risk arrangements earlier in their participation under the program; and policies for reopening of payment determinations to make corrections after financial calculations have been performed and ACO shared savings and shared losses for a performance year have been determined.
935 The Food and Drug Administration (FDA) is announcing the termination of the Transmissible Spongiform Encephalopathies Advisory Committee. This document removes the Transmissible Spongiform Encephalopathies Advisory Committee from the Agency's list of standing advisory committees.
936 The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during March and April 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications and the voluntary withdrawals of approval of applications that occurred in January and February.
937 The Food and Drug Administration (FDA) is withdrawing approval of five new animal drug applications (NADAs) and an abbreviated new animal drug application (ANADA). This action is being taken at the sponsors' request because these products are no longer manufactured or marketed.
938 The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of chromium propionate as a source of chromium in broiler chicken feed. This action is in response to a food additive petition filed by Kemin Industries, Inc.
939 The Department of Health and Human Services is issuing a final regulation that adopts, without change, the interim final rule (IFR) entitled "State Health Insurance Assistance Program (SHIP)." This final rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of the State Health Insurance Assistance Program (SHIP) from the Centers for Medicare & Medicaid Services (CMS), in the Department of Health and Human Services (HHS) to the Administration for Community Living (ACL) in HHS. Prior to the interim final rule, prior regulations were issued by CMS under the authority granted by the Omnibus Budget Reconciliation Act of 1990 (OBRA), Section 4360.
940 This document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled "Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 through 2017."
941 This document corrects technical and typographical errors that appeared in the final rule with comment period published in the November 16, 2015 Federal Register (80 FR 70886 through 71386) entitled "Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016." The effective date for the rule was January 1, 2016.
942 The Food and Drug Administration (FDA) is classifying the diurnal pattern recorder system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the diurnal pattern recorder system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
943 The Food and Drug Administration (FDA or we) is amending its labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The updated information is consistent with current data on the associations between nutrients and chronic diseases, health-related conditions, physiological endpoints, and/or maintaining a healthy dietary pattern that reflects current public health conditions in the United States, and corresponds to new information on consumer understanding and consumption patterns. The final rule updates the list of nutrients that are required or permitted to be declared; provides updated Daily Reference Values and Reference Daily Intake values that are based on current dietary recommendations from consensus reports; amends requirements for foods represented or purported to be specifically for children under the age of 4 years and pregnant and lactating women and establishes nutrient reference values specifically for these population subgroups; and revises the format and appearance of the Nutrition Facts label.
944 The Food and Drug Administration (FDA or we) is issuing a final rule to define a single-serving container; require dual-column labeling for certain containers; update, modify, and establish several reference amounts customarily consumed (RACCs); amend the label serving size for breath mints; and make technical amendments to various aspects of the serving size regulations. We are taking this action to provide consumers with more accurate and up-to-date information on serving sizes.
945 The Food and Drug Administration (FDA or we) is issuing this final rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. FDA is issuing these requirements as part of our implementation of the FDA Food Safety Modernization Act (FSMA).
946 The Food and Drug Administration (FDA) is issuing a final order to reclassify external cardiac compressors (ECC) (under FDA product code DRM), a preamendments class III device, into class II (special controls). FDA is also creating a separate classification regulation for a subgroup of devices previously included within this classification regulation, to be called cardiopulmonary resuscitation (CPR) aids, and reclassifying these devices from class III to class II for CPR aids with feedback and to class I for CPR aids without feedback.
947 This final rule specifies the process and timeline for expanding CMS' existing Medicare Secondary Payer (MSP) Web portal to conform to section 201 of the Medicare IVIG and Strengthening Medicare and Repaying Taxpayers Act of 2012 (the SMART Act). The final rule specifies a timeline for developing a multifactor authentication solution to securely permit authorized users other than the beneficiary to access CMS' MSP conditional payment amounts and claims detail information via the MSP Web portal. It also requires that we add functionality to the existing MSP Web portal that permits users to: Notify us that the specified case is approaching settlement; obtain time and date stamped final conditional payment summary statements and amounts before reaching settlement; and ensure that relatedness disputes and any other discrepancies are addressed within 11 business days of receipt of dispute documentation.
948 The Food and Drug Administration (FDA or we) is issuing a final rule to require that the sponsor of each approved or conditionally approved new animal drug product that contains an antimicrobial active ingredient submit an annual report to us on the amount of each such ingredient in the drug product that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. This final rule codifies the reporting requirements established in section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA). The final rule also includes an additional reporting provision intended to enhance our understanding of antimicrobial new animal drug sales intended for use in specific food- producing animal species and the relationship between such sales and antimicrobial resistance.
949 The Food and Drug Administration (FDA or we) is issuing a final rule that requires domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). FDA recently expanded its authority by issuing a final rule, "Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products" (Deeming rule), deeming all products that meet the statutory definition of "tobacco product," except accessories of the newly deemed tobacco products, to be subject to the FD&C Act. The Deeming rule, among other things, subjected domestic manufacturers and importers of cigars and pipe tobacco to the FD&C Act's user fee requirements. Consistent with the Deeming rule and the requirements of the FD&C Act, this final rule requires the submission of the information needed to calculate user fee assessments for each manufacturer and importer of cigars and pipe tobacco to FDA.
950 The Food and Drug Administration (FDA) is issuing this final rule to deem products meeting the statutory definition of "tobacco product," except accessories of the newly deemed tobacco products, to be subject to the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). The Tobacco Control Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. With this final rule, FDA is extending the Agency's "tobacco product" authorities in the FD&C Act to all other categories of products that meet the statutory definition of "tobacco product" in the FD&C Act, except accessories of such newly deemed tobacco products. This final rule also prohibits the sale of "covered tobacco products" to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. FDA is taking this action to reduce the death and disease from tobacco products. In accordance with the Tobacco Control Act, we consider and intend the extension of our authorities over tobacco products and the various requirements and prohibitions established by this rule to be severable.
951 This final rule modernizes the Medicaid managed care regulations to reflect changes in the usage of managed care delivery systems. The final rule aligns, where feasible, many of the rules governing Medicaid managed care with those of other major sources of coverage, including coverage through Qualified Health Plans and Medicare Advantage plans; implements statutory provisions; strengthens actuarial soundness payment provisions to promote the accountability of Medicaid managed care program rates; and promotes the quality of care and strengthens efforts to reform delivery systems that serve Medicaid and CHIP beneficiaries. It also ensures appropriate beneficiary protections and enhances policies related to program integrity. This final rule also implements provisions of the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) and addresses third party liability for trauma codes.
952 The Food and Drug Administration (FDA or Agency or we) is amending the general biological products standards relating to dating periods and also removing certain standards relating to standard preparations and limits of potency. FDA is taking this action to update outdated requirements, and accommodate new and evolving technology and testing capabilities, without diminishing public health protections. This action is part of FDA's retrospective review of its regulations in response to an Executive order. FDA is issuing these amendments directly as a final rule because the Agency believes they are noncontroversial and FDA anticipates no significant adverse comments.
953 This final rule will amend the fire safety standards for Medicare and Medicaid participating hospitals, critical access hospitals (CAHs), long-term care facilities, intermediate care facilities for individuals with intellectual disabilities (ICF-IID), ambulatory surgery centers (ASCs), hospices which provide inpatient services, religious non-medical health care institutions (RNHCIs), and programs of all-inclusive care for the elderly (PACE) facilities. Further, this final rule will adopt the 2012 edition of the Life Safety Code (LSC) and eliminate references in our regulations to all earlier editions of the Life Safety Code. It will also adopt the 2012 edition of the Health Care Facilities Code, with some exceptions.
954 The Food and Drug Administration (FDA or we) is amending a final rule that published in the Federal Register of November 27, 2015. That final rule established science-based minimum standards for the safe growing, harvesting, packing, and holding of produce, meaning fruits and vegetables grown for human consumption. The rule sets forth procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. FDA established these standards as part of our implementation of the FDA Food Safety and Modernization Act. The final rule published with some editorial and inadvertent errors. This document corrects those errors.
955 The Food and Drug Administration (FDA) published a document in the Federal Register of April 18, 2016 (81 FR 22520), amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. That rule included two amendatory instructions that cited incorrect sections of 21 CFR part 524.
956 The Food and Drug Administration (FDA) is amending a final rule published in the Federal Register of November 27, 2015. That final rule established requirements for importers to verify that food they import into the United States is produced consistent with the hazard analysis and risk-based preventive controls and standards for produce safety provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), is not adulterated, and is not misbranded with respect to food allergen labeling. The final rule published with some editorial and inadvertent errors. This document corrects those errors.
957 This interim final rule with comment period (IFC) implements section 231 of the Consolidated Appropriations Act of 2016 (CAA), which provides for a temporary exception for certain wound care discharges from the application of the site neutral payment rate under the Long- Term Care Hospital (LTCH) Prospective Payment System (PPS) for certain long-term care hospitals. This IFC also amends our current regulations to allow hospitals nationwide to reclassify based on their acquired rural status, effective with reclassifications beginning with fiscal year (FY) 2018. Hospitals with an existing Medicare Geographic Classification Review Board (MGCRB) reclassification would also have the opportunity to seek rural reclassification for IPPS payment and other purposes and keep their existing MGCRB reclassification. We would also apply the policy in this IFC when deciding timely appeals before the Administrator under our regulations for FY 2017 that were denied by the MGCRB due to existing regulations, which do not permit simultaneous rural reclassification for IPPS payment and other purposes and MGCRB reclassification. These regulatory changes implement the decisions in Geisinger Community Medical Center v. Secretary, United States Department of Health and Human Services, 794 F.3d 383 (3d Cir. 2015) and Lawrence + Memorial Hospital v. Burwell, No. 15-164, 2016 WL 423702 (2d Cir. Feb. 4, 2015) in a nationally consistent manner.
958 The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in January and February.
959 The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code DTE), into class II (special controls) and to reclassify pacing system analyzers (PSAs) into class II (special controls) based on new information and subject to premarket notification. This final order also creates a separate classification regulation for PSAs and places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.
960 The Food and Drug Administration (FDA or we) is amending the food additive regulations to provide for the safe use of folic acid in corn masa flour. We are taking this action in response to a food additive petition filed jointly by Gruma Corporation, Spina Bifida Association, March of Dimes Foundation, American Academy of Pediatrics, Royal DSM N.V., and National Council of La Raza.
961 The Food and Drug Administration (FDA or we) is announcing the availability of a guidance for industry entitled ``Exempt Infant Formula Production: Current Good Manufacturing Practices (CGMPs), Quality Control Procedures, Conduct of Audits, and Records and Reports.'' The guidance describes our current thinking on the manufacturing of exempt infant formula in relation to the requirements for CGMPs, quality control procedures, conduct of audits, and records and reports that apply to non-exempt infant formulas.
962 In the November 2, 2015 Federal Register, we published a final rule with comment period entitled "Medicaid Program: Methods for Assuring Access to Covered Medicaid Services." The final rule with comment period established that states must develop and submit to CMS an access monitoring review plan by July 1, 2016. This document revises the deadline for states' access monitoring review plan submission to CMS until October 1, 2016.
963 The Food and Drug Administration (FDA or we) is issuing a final rule to establish requirements for shippers, loaders, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure the safety of the food they transport. This action is part of our larger effort to focus on prevention of food safety problems throughout the food chain and is part of our implementation of the Sanitary Food Transportation Act of 2005 (2005 SFTA) and the Food Safety Modernization Act of 2011 (FSMA).
964 The Food and Drug Administration (FDA) is amending the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA's IRB regulations. We are clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions until the noncompliance with FDA's IRB regulations is corrected. We are taking this action to ensure clarity and improve the accuracy of the regulations.
965
966 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during November and December 2015. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to reflect changes of sponsorship of applications that occurred in November and December 2015.
967 This final rule will address the application of certain requirements set forth in the Public Health Service Act, as amended by the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, to coverage offered by Medicaid managed care organizations, Medicaid Alternative Benefit Plans, and Children's Health Insurance Programs.
968 The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER). FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems (bioequivalence regulations) to correct a typographical error. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.
969 The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to add the Patient Engagement Advisory Committee.
970 The Food and Drug Administration (FDA or we) is issuing a final rule prohibiting the use of certain cattle material to address the potential risk of bovine spongiform encephalopathy (BSE) in human food, including dietary supplements, and cosmetics. We have designated the following items as prohibited cattle materials: Specified risk materials (SRMs), the small intestine from all cattle (unless the distal ileum has been removed), material from nonambulatory disabled cattle, material from cattle not inspected and passed, or mechanically separated (MS) (Beef). We are taking this action to minimize human exposure to certain cattle material that could potentially contain the BSE agent.
971
972 This document corrects technical and typographical errors that appeared in the final rule with comment period published in the November 16, 2015 Federal Register (80 FR 70886 through 71386) entitled "Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2016."
973 The Food and Drug Administration (FDA) is amending the standing advisory committees' regulations to change the name of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. This action is being taken to reflect the change made to the charter for this advisory committee.
974 The Food and Drug Administration (FDA) is removing regulations that required sponsors to submit data regarding the subtherapeutic use of certain antibiotic, nitrofuran, and sulfonamide drugs administered in animal feed as these regulations have been determined to be obsolete. FDA has other strategies for assessing the safety of antimicrobial new animal drugs with regard to their microbiological effects on bacteria of human health concern, and the only remaining animal drug use listed in these regulations is now listed elsewhere in the new animal drug regulations.
975 The Food and Drug Administration (FDA or Agency) is amending the Unique Device Identification (UDI) System regulation to make editorial changes. This technical amendment updates the email address associated with FDA's UDI system, which allows FDA to obtain information and offer support and assistance on medical devices through their distribution and use, ensuring consistency with the requirements in the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This change is necessary to ensure that the UDI team continues to maintain regular email communications with device labelers.
976
977 This document corrects certain technical and typographical errors that appeared in the October 16, 2015 final rule with comment period titled "Medicare and Medicaid Programs; Electronic Health Record Incentive Program--Stage 3 and Modifications to Meaningful Use in 2015 through 2017."
978 In the November 24, 2015 Federal Register (80 FR 73274), we published a final rule to implement a new Medicare Part A and B payment model under section 1115A of the Social Security Act, called the Comprehensive Care for Joint Replacement (CJR) model, in which acute care hospitals in certain selected geographic areas will receive retrospective bundled payments for episodes of care for lower extremity joint replacement (LEJR) or reattachment of a lower extremity. The effective date was January 15, 2016. This correcting amendment corrects a limited number of technical and typographical errors identified in the November 24, 2015 final rule.
979 This document provides the methodology and data sources necessary to determine Federal payment amounts made in program years 2017 and 2018 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low- income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges (hereinafter referred to as the Exchanges).
980 The Food and Drug Administration (FDA or we) is announcing a public meeting entitled "FDA Food Safety Modernization Act: Prevention-Oriented Import System Regulations and Implementation." The public meeting will provide importers and other interested persons an opportunity to discuss import safety regulations and programs, including final rules for foreign supplier verification programs (FSVPs) for importers of food for humans and animals (the FSVP final rule) and accreditation of third-party certification bodies (the third- party certification final rule). Participants will also be briefed on the status of FDA's Voluntary Qualified Importer Program (VQIP), which is still in development. Additionally, the public meeting will provide importers and other interested persons an opportunity to discuss FDA's comprehensive planning effort for the next phase of the FDA Food Safety Modernization Act implementation relating to import safety programs, which includes establishing the operational framework for these programs and plans for guidance documents, training, education, and technical assistance.
981 The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a guidance for industry entitled "Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids-- Small Entity Compliance Guide." The small entity compliance guide (SECG) is intended to help small entities comply with the final rule titled "Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids."
982 The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis; and hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
983 The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.
984 The Food and Drug Administration (FDA) is issuing a final order to redesignate membrane lung devices for long-term pulmonary support, a preamendments class III device, as extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure, and to reclassify the device to class II (special controls) in patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed, and continued clinical deterioration is expected or the risk of death is imminent. A membrane lung device for long-term pulmonary support (>6 hours) refers to the oxygenator in an extracorporeal circuit used during long-term procedures, commonly referred to as extracorporeal membrane oxygenation (ECMO). Because a number of other devices and accessories are used with the oxygenator in the circuit, the title and identification of the regulation are revised to include extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure. Although an individual device or accessory used in an ECMO circuit may already have its own classification regulation when the device or accessory is intended for short-term use (<=6 hours), such device or accessory will be subject to the same regulatory controls applied to the oxygenator (i.e., class II, special controls) when evaluated as part of the ECMO circuit for long- term use (>6 hours). On its own initiative, based on new information, FDA is revising the classification of the membrane lung device for long-term pulmonary support.
985 The Food and Drug Administration (FDA) is classifying the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
986 This final rule requires providers and suppliers receiving funds under the Medicare program to report and return overpayments by the later of the date that is 60 days after the date on which the overpayment was identified; or the date any corresponding cost report is due, if applicable. The requirements in this rule are meant to ensure compliance with applicable statutes, promote the furnishing of high quality care, and to protect the Medicare Trust Funds against fraud and improper payments. This rule provides needed clarity and consistency in the reporting and returning of self-identified overpayments.
987 This rule implements a provision enacted by the Consolidated Appropriations Act of 2014 and reflects the transfer of the State Health Insurance Assistance Program (SHIP) from the Centers for Medicare & Medicaid Services (CMS), in the Department of Health and Human Services (HHS) to the Administration for Community Living (ACL) in HHS. The previous regulations were issued by CMS under the authority granted by the Omnibus Budget Reconciliation Act of 1990 (OBRA `90), Section 4360.
988 The Food and Drug Administration (FDA or we) is amending certain regulations to update the location of references cited in our food regulations. We are taking this action to reflect the transfer of those references from our facility in College Park, MD, to our library at our main campus in Silver Spring, MD. We also are updating certain regulations to reflect the current names for specific FDA offices.
989 This final rule revises the Medicaid home health service definition consistent with section 6407 of the Patient Protection and Affordable Care Act of 2010 (the Affordable Care Act) and section 504 of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) to add requirements that, for home health services, physicians document, and, for certain medical equipment, physicians or certain authorized non-physician practitioners (NPP) document the occurrence of a face-to- face encounter (including through the use of telehealth) with the Medicaid eligible beneficiary within reasonable timeframes. This rule also aligns the timeframes for the face-to-face encounter with similar regulatory requirements for Medicare home health services. In addition, this rule amends the definitions of medical supplies, equipment, and appliances. We expect minimal impact with the implementation of section 6407 of the Affordable Care Act and section 504 of MACRA. We recognize that states may have budgetary implications as a result of the amended definitions of medical supplies, equipment and appliances. Specifically, this rule may expand coverage of medical supplies, equipment and appliances under the home health benefit. There will be items that had previously only been offered under certain sections of the Act that will now be covered under the home health benefit.
990 This final rule implements provisions of the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act) pertaining to Medicaid reimbursement for covered outpatient drugs (CODs). This final rule also revises other requirements related to CODs, including key aspects of their Medicaid coverage and payment and the Medicaid drug rebate program.
991 The Food and Drug Administration (FDA or we) is correcting a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for "farms." The final rule published with some editorial and inadvertent errors. This document corrects those errors.
992 In accordance with court rulings in cases that challenge the federal fiscal year (FY) 2004 outlier fixed-loss threshold rulemaking, this document provides further explanation of certain methodological choices made in the FY 2004 fixed-loss threshold determination.
993 The Food and Drug Administration (FDA or we) is amending a final rule that published in the Federal Register of September 17, 2015. That final rule amended our regulation for current good manufacturing practice in manufacturing, packing, or holding human food to modernize it, and to add requirements for domestic and foreign facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish and implement hazard analysis and risk-based preventive controls for human food. That final rule also revised certain definitions in our current regulation for registration of food facilities to clarify the scope of the exemption from registration requirements provided by the FD&C Act for "farms." The final rule published with some editorial and inadvertent errors. This document corrects those errors.
994 The Food and Drug Administration (FDA or we) is amending a final rule that published in the Federal Register of September 17, 2015. That final rule established requirements for domestic and foreign facilities required to register under the Federal Food, Drug, and Cosmetic Act for current good manufacturing practice, hazard analysis, and risk-based preventive controls for food for animals. The final rule published with some editorial and inadvertent errors. This document corrects those errors.
995 The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect that the conditional approval of an application for masitinib mesylate tablets, a new animal drug for a minor use, is no longer in effect.
996 The Food and Drug Administration (FDA) is classifying the tympanic membrane contact hearing aid into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the tympanic membrane contact hearing aid's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
997 The Food and Drug Administration (FDA) is classifying the intravaginal culture system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the intravaginal culture system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
998 The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III. FDA is reclassifying these devices based on the determination that general controls and special controls together are not sufficient to provide reasonable assurance of safety and effectiveness for this device, and these devices present a potential unreasonable risk of illness or injury. The Agency is reclassifying surgical mesh for transvaginal POP repair on its own initiative based on new information.
999 The Food and Drug Administration (FDA or the Agency) is issuing a final order to require the filing of a premarket approval application (PMA) or notice of completion of a product development protocol (PDP) for surgical mesh for transvaginal pelvic organ prolapse (POP) repair.
1000 The Food and Drug Administration (FDA or we) is amending the food additive regulations to no longer provide for the use of three specific perfluoroalkyl ethyl containing food-contact substances (FCSs) as oil and water repellants for paper and paperboard for use in contact with aqueous and fatty foods because new data are available as to the toxicity of substances structurally similar to these compounds that demonstrate there is no longer a reasonable certainty of no harm from the food-contact use of these FCSs. This action is in response to a petition filed by the Natural Resources Defense Council, the Center for Food Safety, the Breast Cancer Fund, the Center for Environmental Health, Clean Water Action, the Center for Science in the Public Interest, Children's Environmental Health Network, Environmental Working Group, and Improving Kids' Environment.
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html_url
1 https://www.federalregister.gov/documents/2024/10/30/2024-25122/indirect-food-additives-adhesives-and-components-of-coatings-paper-and-paperboard-components
2 https://www.federalregister.gov/documents/2024/10/28/2024-24820/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsor-change-of-sponsor
3 https://www.federalregister.gov/documents/2024/10/28/2024-24910/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2025
4 https://www.federalregister.gov/documents/2024/10/25/2024-24801/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-advancing-interoperability
5 https://www.federalregister.gov/documents/2024/10/24/2024-24715/food-and-drug-administration-enforcement-policy-for-association-of-american-feed-control
6 https://www.federalregister.gov/documents/2024/10/18/2024-24100/regulatory-hearing-before-the-food-and-drug-administration-general-provisions-amendments-correction
7 https://www.federalregister.gov/documents/2024/10/15/2024-23195/medicare-program-appeal-rights-for-certain-changes-in-patient-status
8 https://www.federalregister.gov/documents/2024/10/15/2024-23701/medical-devices-quality-system-regulation-amendments-correction
9 https://www.federalregister.gov/documents/2024/10/03/2024-22765/medicare-program-changes-to-the-fiscal-year-2025-hospital-inpatient-prospective-payment-system-ipps
10 https://www.federalregister.gov/documents/2024/10/02/2024-22496/medicare-program-fy-2025-inpatient-psychiatric-facilities-prospective-payment-system-rate-update
11 https://www.federalregister.gov/documents/2024/10/02/2024-22501/medicare-and-medicaid-programs-and-the-childrens-health-insurance-program-hospital-inpatient
12 https://www.federalregister.gov/documents/2024/10/02/2024-22497/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal
13 https://www.federalregister.gov/documents/2024/10/02/2024-22504/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities
14 https://www.federalregister.gov/documents/2024/10/01/2024-22495/medicare-program-fy-2025-hospice-wage-index-and-payment-rate-update-hospice-conditions-of
15 https://www.federalregister.gov/documents/2024/09/30/2024-22203/medicare-program-changes-to-the-medicare-advantage-and-the-medicare-prescription-drug-benefit
16 https://www.federalregister.gov/documents/2024/09/27/2024-22054/medicare-program-mitigating-the-impact-of-significant-anomalous-and-highly-suspect-billing-activity
17 https://www.federalregister.gov/documents/2024/09/26/2024-21254/medicaid-program-misclassification-of-drugs-program-administration-and-program-integrity-updates
18 https://www.federalregister.gov/documents/2024/09/24/2024-21840/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-what-you
19 https://www.federalregister.gov/documents/2024/09/23/2024-21616/microbiology-devices-reclassification-of-cytomegalovirus-deoxyribonucleic-acid-quantitative-assay
20 https://www.federalregister.gov/documents/2024/09/20/2024-21231/regulatory-hearing-before-the-food-and-drug-administration-general-provisions-amendments
21 https://www.federalregister.gov/documents/2024/09/17/2024-21086/medical-devices-immunology-and-microbiology-devices-classification-of-the-quantitative-viral-nucleic
22 https://www.federalregister.gov/documents/2024/09/16/2024-20895/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-clozapine
23 https://www.federalregister.gov/documents/2024/09/16/2024-20896/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-or
24 https://www.federalregister.gov/documents/2024/09/16/2024-20999/medical-devices-therapeutic-devices-classification-of-the-pediatric-continuous-renal-replacement
25 https://www.federalregister.gov/documents/2024/09/13/2024-20850/enforcement-policy-for-required-warnings-for-cigarette-packages-and-advertisements-guidance-for
26 https://www.federalregister.gov/documents/2024/09/11/2024-20550/medical-devices-immunology-and-microbiology-devices-classification-of-the-whole-exome-sequencing
27 https://www.federalregister.gov/documents/2024/09/09/2024-20254/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-blood
28 https://www.federalregister.gov/documents/2024/09/09/2024-20248/medical-devices-gastroenterology-urology-devices-classification-of-the-endoscopic-pancreatic
29 https://www.federalregister.gov/documents/2024/09/09/2024-20174/medicare-program-medicare-prescription-drug-benefit-program-health-information-technology-standards
30 https://www.federalregister.gov/documents/2024/09/06/2024-20081/medical-devices-gastroenterology-urology-devices-classification-of-the-hemodialyzer-with-expanded
31 https://www.federalregister.gov/documents/2024/09/05/2024-19856/food-additives-permitted-in-feed-and-drinking-water-of-animals-pichia-pastoris-dried-yeast
32 https://www.federalregister.gov/documents/2024/09/05/2024-19824/medical-devices-hematology-and-pathology-devices-classification-of-the-heparin-and-direct-oral
33 https://www.federalregister.gov/documents/2024/09/05/2024-19736/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-open-loop-fluid-therapy
34 https://www.federalregister.gov/documents/2024/09/05/2024-19868/medical-devices-dental-devices-classification-of-the-radiofrequency-toothbrush
35 https://www.federalregister.gov/documents/2024/09/05/2024-19882/medical-devices-ophthalmic-devices-classification-of-the-hydrophilic-re-coating-solution
36 https://www.federalregister.gov/documents/2024/09/03/2024-19725/medical-devices-dental-devices-classification-of-the-neuromuscular-tongue-muscle-stimulator-for-the
37 https://www.federalregister.gov/documents/2024/09/03/2024-19720/medical-devices-neurological-devices-classification-of-the-digital-therapy-device-for-attention
38 https://www.federalregister.gov/documents/2024/09/03/2024-19726/medical-devices-orthopedic-devices-classification-of-the-intervertebral-body-graft-containment
39 https://www.federalregister.gov/documents/2024/09/03/2024-19722/medical-devices-physical-medicine-devices-classification-of-the-external-compression-device-for
40 https://www.federalregister.gov/documents/2024/08/30/2024-19481/prohibition-of-sale-of-tobacco-products-to-persons-younger-than-21-years-of-age
41 https://www.federalregister.gov/documents/2024/08/29/2024-19414/medical-devices-and-device-led-combination-products-voluntary-malfunction-summary-reporting-for
42 https://www.federalregister.gov/documents/2024/08/28/2024-17021/medicare-and-medicaid-programs-and-the-childrens-health-insurance-program-hospital-inpatient
43 https://www.federalregister.gov/documents/2024/08/26/2024-19059/mammography-quality-standards-act-and-regulation-amendments-small-entity-compliance-guide-guidance
44 https://www.federalregister.gov/documents/2024/08/22/2024-18824/food-additives-permitted-in-feed-and-drinking-water-of-animals-fermented-ammoniated-condensed-whey
45 https://www.federalregister.gov/documents/2024/08/16/2024-18266/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-and
46 https://www.federalregister.gov/documents/2024/08/16/2024-18264/medical-devices-immunology-and-microbiology-devices-classification-of-the-device-to-detect-and
47 https://www.federalregister.gov/documents/2024/08/16/2024-18267/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-intravenous-catheter
48 https://www.federalregister.gov/documents/2024/08/07/2024-16909/medicare-program-fy-2025-inpatient-psychiatric-facilities-prospective-payment-system-rate-update
49 https://www.federalregister.gov/documents/2024/08/06/2024-17024/medicare-program-changes-to-the-medicare-advantage-and-the-medicare-prescription-drug-benefit
50 https://www.federalregister.gov/documents/2024/08/06/2024-16907/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities
51 https://www.federalregister.gov/documents/2024/08/06/2024-16910/medicare-program-fy-2025-hospice-wage-index-and-payment-rate-update-hospice-conditions-of
52 https://www.federalregister.gov/documents/2024/08/06/2024-16911/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal
53 https://www.federalregister.gov/documents/2024/07/18/2024-15228/blood-pressure-and-pulse-donor-eligibility-requirements-compliance-policy-guidance-for-industry
54 https://www.federalregister.gov/documents/2024/07/17/2024-15644/medicare-program-alternative-payment-model-apm-incentive-payment-advisory-for-clinicians-request-for
55 https://www.federalregister.gov/documents/2024/07/10/2024-15136/advisory-committee-allergenic-products-advisory-committee-termination-removal-from-list-of-standing
56 https://www.federalregister.gov/documents/2024/07/03/2024-14300/revocation-of-authorization-for-use-of-brominated-vegetable-oil-in-food
57 https://www.federalregister.gov/documents/2024/07/01/2024-13793/21st-century-cures-act-establishment-of-disincentives-for-health-care-providers-that-have-committed
58 https://www.federalregister.gov/documents/2024/06/27/2024-14030/medicaid-program-ensuring-access-to-medicaid-services-correction
59 https://www.federalregister.gov/documents/2024/06/24/2024-13712/medicaid-program-medicaid-and-childrens-health-insurance-program-chip-managed-care-access-finance
60 https://www.federalregister.gov/documents/2024/06/24/2024-13795/medicare-and-medicaid-programs-minimum-staffing-standards-for-long-term-care-facilities-and-medicaid
61 https://www.federalregister.gov/documents/2024/06/21/2024-13678/medicated-feed-mill-license-veterinary-feed-directive-drugs-change-of-address
62 https://www.federalregister.gov/documents/2024/06/18/2024-13190/current-good-manufacturing-practice-certification-postmarketing-safety-reporting-and-labeling
63 https://www.federalregister.gov/documents/2024/06/17/2024-12842/medicare-program-medicare-prescription-drug-benefit-program-health-information-technology-standards
64 https://www.federalregister.gov/documents/2024/06/07/2024-12533/food-additives-permitted-in-feed-and-drinking-water-of-animals-ethyl-cellulose
65 https://www.federalregister.gov/documents/2024/06/03/2024-12027/laboratory-accreditation-for-analyses-of-foods-program-implementation-determination-of-sufficient
66 https://www.federalregister.gov/documents/2024/05/31/2024-11564/administrative-destruction
67 https://www.federalregister.gov/documents/2024/05/30/2024-11811/advisory-committee-science-advisory-board-to-the-national-center-for-toxicological-research
68 https://www.federalregister.gov/documents/2024/05/20/2024-10895/ophthalmic-devices-reclassification-of-ultrasound-cyclodestructive-device
69 https://www.federalregister.gov/documents/2024/05/15/2024-10602/index-of-legally-marketed-unapproved-new-animal-drugs-for-minor-species
70 https://www.federalregister.gov/documents/2024/05/15/2024-10586/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug
71 https://www.federalregister.gov/documents/2024/05/13/2024-10356/medicare-program-updates-to-the-master-list-of-items-potentially-subject-to-face-to-face-encounter
72 https://www.federalregister.gov/documents/2024/05/10/2024-08273/medicare-and-medicaid-programs-minimum-staffing-standards-for-long-term-care-facilities-and-medicaid
73 https://www.federalregister.gov/documents/2024/05/10/2024-08085/medicaid-program-medicaid-and-childrens-health-insurance-program-chip-managed-care-access-finance
74 https://www.federalregister.gov/documents/2024/05/10/2024-08363/medicaid-program-ensuring-access-to-medicaid-services
75 https://www.federalregister.gov/documents/2024/05/08/2024-09661/clarifying-the-eligibility-of-deferred-action-for-childhood-arrivals-daca-recipients-and-certain
76 https://www.federalregister.gov/documents/2024/05/06/2024-08935/medical-devices-laboratory-developed-tests
77 https://www.federalregister.gov/documents/2024/05/06/2024-09153/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption-relating
78 https://www.federalregister.gov/documents/2024/05/06/2024-08711/nondiscrimination-in-health-programs-and-activities
79 https://www.federalregister.gov/documents/2024/04/29/2024-09073/food-additives-permitted-in-feed-and-drinking-water-of-animals-condensed-extracted-glutamic-acid
80 https://www.federalregister.gov/documents/2024/04/29/2024-08955/revocation-of-uses-of-partially-hydrogenated-oils-in-foods-guidance-for-industry-small-entity
81 https://www.federalregister.gov/documents/2024/04/23/2024-07105/medicare-program-changes-to-the-medicare-advantage-and-the-medicare-prescription-drug-benefit
82 https://www.federalregister.gov/documents/2024/04/15/2024-07274/patient-protection-and-affordable-care-act-hhs-notice-of-benefit-and-payment-parameters-for-2025
83 https://www.federalregister.gov/documents/2024/04/10/2024-07522/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities
84 https://www.federalregister.gov/documents/2024/04/02/2024-06566/medicaid-program-streamlining-the-medicaid-childrens-health-insurance-program-and-basic-health
85 https://www.federalregister.gov/documents/2024/03/22/2024-05802/food-additives-food-contact-substance-notification-that-is-no-longer-effective
86 https://www.federalregister.gov/documents/2024/03/15/2024-05473/medical-devices-technical-amendments
87 https://www.federalregister.gov/documents/2024/03/15/2024-04598/frozen-cherry-pie-revocation-of-a-standard-of-identity-and-a-standard-of-quality
88 https://www.federalregister.gov/documents/2024/03/11/2024-05210/principles-of-reasonable-cost-reimbursement-payment-for-end-stage-renal-disease-services
89 https://www.federalregister.gov/documents/2024/03/06/2024-04751/advisory-committee-genetic-metabolic-diseases-advisory-committee-addition-to-list-of-standing
90 https://www.federalregister.gov/documents/2024/03/05/2024-04590/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and
91 https://www.federalregister.gov/documents/2024/02/27/2024-03765/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug
92 https://www.federalregister.gov/documents/2024/02/26/2024-03777/user-fees-technical-amendment
93 https://www.federalregister.gov/documents/2024/02/23/2024-03542/medicaid-program-disproportionate-share-hospital-third-party-payer-rule
94 https://www.federalregister.gov/documents/2024/02/22/2024-03618/advisory-committee-digital-health-advisory-committee-addition-to-list-of-standing-committees
95 https://www.federalregister.gov/documents/2024/02/12/2024-02741/biologics-license-applications-and-master-files
96 https://www.federalregister.gov/documents/2024/02/12/2024-02705/medicare-and-medicaid-programs-cy-2024-payment-policies-under-the-physician-fee-schedule-and-other
97 https://www.federalregister.gov/documents/2024/02/09/2024-02631/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment
98 https://www.federalregister.gov/documents/2024/02/08/2024-02576/sensient-colors-llc-filing-of-color-additive-petition
99 https://www.federalregister.gov/documents/2024/02/08/2024-00895/medicare-and-medicaid-programs-patient-protection-and-affordable-care-act-advancing-interoperability
100 https://www.federalregister.gov/documents/2024/02/02/2024-01709/medical-devices-quality-system-regulation-amendments
101 https://www.federalregister.gov/documents/2024/02/01/2024-01942/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and
102 https://www.federalregister.gov/documents/2024/01/31/2024-01094/medicare-program-calendar-year-cy-2024-home-health-hh-prospective-payment-system-rate-update-hh
103 https://www.federalregister.gov/documents/2024/01/30/2024-01796/food-additives-permitted-in-feed-and-drinking-water-of-animals-chromium-propionate
104 https://www.federalregister.gov/documents/2024/01/23/2024-01106/listing-of-color-additives-exempt-from-certification-jagua-genipin-glycine-blue-confirmation-of
105 https://www.federalregister.gov/documents/2023/12/28/2023-28170/clinical-laboratory-improvement-amendments-of-1988-clia-fees-histocompatibility-personnel-and
106 https://www.federalregister.gov/documents/2023/12/27/2023-28530/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear
107 https://www.federalregister.gov/documents/2023/12/21/2023-27935/institutional-review-board-waiver-or-alteration-of-informed-consent-for-minimal-risk-clinical
108 https://www.federalregister.gov/documents/2023/12/19/2023-27857/food-additives-permitted-in-feed-and-drinking-water-of-animals-calcium-formate
109 https://www.federalregister.gov/documents/2023/12/14/2023-27506/revocation-of-uses-of-partially-hydrogenated-oils-in-foods-confirmation-of-effective-date
110 https://www.federalregister.gov/documents/2023/12/06/2023-26545/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug
111 https://www.federalregister.gov/documents/2023/12/06/2023-26640/medicaid-cms-enforcement-of-state-compliance-with-reporting-and-federal-medicaid-renewal
112 https://www.federalregister.gov/documents/2023/11/28/2023-26095/milk-and-cream-products-and-yogurt-products-final-rule-to-revoke-the-standards-for-lowfat-yogurt-and
113 https://www.federalregister.gov/documents/2023/11/27/2023-25696/medicare-program-medicare-secondary-payer-and-certain-civil-money-penalties-correction
114 https://www.federalregister.gov/documents/2023/11/22/2023-24293/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment
115 https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear
116 https://www.federalregister.gov/documents/2023/11/17/2023-25408/medicare-and-medicaid-programs-disclosures-of-ownership-and-additional-disclosable-parties
117 https://www.federalregister.gov/documents/2023/11/16/2023-24184/medicare-and-medicaid-programs-cy-2024-payment-policies-under-the-physician-fee-schedule-and-other
118 https://www.federalregister.gov/documents/2023/11/13/2023-24455/medicare-program-calendar-year-cy-2024-home-health-hh-prospective-payment-system-rate-update-hh
119 https://www.federalregister.gov/documents/2023/11/09/2023-24717/medical-devices-hematology-and-pathology-devices-classification-of-the-container-system-for-the
120 https://www.federalregister.gov/documents/2023/11/09/2023-24670/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the
121 https://www.federalregister.gov/documents/2023/11/08/2023-24407/medicare-program-hospital-outpatient-prospective-payment-system-remedy-for-the-340b-acquired-drug
122 https://www.federalregister.gov/documents/2023/11/06/2023-23915/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis
123 https://www.federalregister.gov/documents/2023/11/03/2023-24352/listing-of-color-additives-exempt-from-certification-jagua-genipin-glycine-blue
124 https://www.federalregister.gov/documents/2023/10/18/2023-22957/compliance-policy-regarding-blood-and-blood-component-donation-suitability-donor-eligibility-and
125 https://www.federalregister.gov/documents/2023/10/13/2023-22649/prior-notice-of-imported-food-questions-and-answers-edition-4-guidance-for-industry-availability
126 https://www.federalregister.gov/documents/2023/10/11/2023-22282/medicare-program-medicare-secondary-payer-and-certain-civil-money-penalties
127 https://www.federalregister.gov/documents/2023/10/04/2023-22060/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the
128 https://www.federalregister.gov/documents/2023/10/04/2023-22050/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities
129 https://www.federalregister.gov/documents/2023/10/04/2023-22053/medicare-program-fy-2024-inpatient-psychiatric-facilities-prospective-payment-system-rate-update
130 https://www.federalregister.gov/documents/2023/10/04/2023-22051/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal
131 https://www.federalregister.gov/documents/2023/09/26/2023-20746/requirements-for-additional-traceability-records-for-certain-foods-technical-amendment
132 https://www.federalregister.gov/documents/2023/09/21/2023-20382/streamlining-medicaid-medicare-savings-program-eligibility-determination-and-enrollment
133 https://www.federalregister.gov/documents/2023/09/19/2023-20012/advisory-committee-board-of-tea-experts-termination-and-technical-amendment-to-the-citation-for-the
134 https://www.federalregister.gov/documents/2023/09/01/2023-18899/wholesale-distributor-verification-requirement-for-saleable-returned-drug-product-and-dispenser
135 https://www.federalregister.gov/documents/2023/09/01/C2-2022-23918/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment
136 https://www.federalregister.gov/documents/2023/08/31/2023-18669/medicaid-program-and-chip-mandatory-medicaid-and-childrens-health-insurance-program-chip-core-set
137 https://www.federalregister.gov/documents/2023/08/28/2023-18359/enhanced-drug-distribution-security-requirements-under-section-582g1-of-the-federal-food-drug-and
138 https://www.federalregister.gov/documents/2023/08/28/2023-16252/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the
139 https://www.federalregister.gov/documents/2023/08/24/C1-2022-23918/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment
140 https://www.federalregister.gov/documents/2023/08/16/2023-17454/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug
141 https://www.federalregister.gov/documents/2023/08/09/2023-16725/revocation-of-uses-of-partially-hydrogenated-oils-in-foods
142 https://www.federalregister.gov/documents/2023/08/07/2023-16249/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities
143 https://www.federalregister.gov/documents/2023/08/02/2023-16050/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal
144 https://www.federalregister.gov/documents/2023/08/02/2023-16083/medicare-program-fy-2024-inpatient-psychiatric-facilities-prospective-payment-system-rate-update
145 https://www.federalregister.gov/documents/2023/08/02/2023-16116/medicare-program-fy-2024-hospice-wage-index-and-payment-rate-update-hospice-conditions-of
146 https://www.federalregister.gov/documents/2023/08/01/2023-16307/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program
147 https://www.federalregister.gov/documents/2023/07/31/2023-16140/medicare-program-alternative-payment-model-apm-incentive-payment-advisory-for-clinicians-request-for
148 https://www.federalregister.gov/documents/2023/07/14/2023-14716/nomenclature-change-for-dockets-management-technical-amendment
149 https://www.federalregister.gov/documents/2023/06/09/2023-12308/medicare-program-treatment-of-medicare-part-c-days-in-the-calculation-of-a-hospitals-medicare
150 https://www.federalregister.gov/documents/2023/06/07/2023-12098/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program
151 https://www.federalregister.gov/documents/2023/06/05/2023-11449/medicare-and-medicaid-programs-policy-and-regulatory-changes-to-the-omnibus-covid-19-health-care
152 https://www.federalregister.gov/documents/2023/05/31/2023-11550/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program
153 https://www.federalregister.gov/documents/2023/05/24/2023-10602/food-labeling-infant-formula-requirements-food-additives-and-generally-recognized-as-safe-substances
154 https://www.federalregister.gov/documents/2023/05/19/2023-10666/requirements-for-additional-traceability-records-for-certain-foods-what-you-need-to-know-about-the
155 https://www.federalregister.gov/documents/2023/05/18/2023-10606/international-dairy-foods-association-response-to-the-objections-and-requests-for-a-public-hearing
156 https://www.federalregister.gov/documents/2023/05/03/2023-09212/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug
157 https://www.federalregister.gov/documents/2023/05/02/2023-09188/medicare-program-extending-the-medicare-diabetes-prevention-programs-mdpp-expanded-model-emergency
158 https://www.federalregister.gov/documents/2023/04/14/2023-07723/international-dairy-foods-association-response-to-the-objections-and-requests-for-a-public-hearing
159 https://www.federalregister.gov/documents/2023/04/12/2023-07115/medicare-program-contract-year-2024-policy-and-technical-changes-to-the-medicare-advantage-program
160 https://www.federalregister.gov/documents/2023/03/30/2023-06565/effective-date-of-requirement-for-premarket-approval-applications-for-spinal-spheres-for-use-in
161 https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinal-spheres-for-use-in-intervertebral-fusion
162 https://www.federalregister.gov/documents/2023/03/27/2023-06260/change-of-address-technical-amendment
163 https://www.federalregister.gov/documents/2023/03/24/2023-05418/food-labeling-infant-formula-requirements-food-additives-and-generally-recognized-as-safe-substances
164 https://www.federalregister.gov/documents/2023/03/21/2023-05657/medical-devices-technical-amendments
165 https://www.federalregister.gov/documents/2023/03/20/2023-05465/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsor
166 https://www.federalregister.gov/documents/2023/03/20/2023-03950/definition-of-the-term-tobacco-product-in-regulations-issued-under-the-federal-food-drug-and
167 https://www.federalregister.gov/documents/2023/03/16/2023-05361/listing-of-color-additives-exempt-from-certification-spirulina-extract-confirmation-of-effective
168 https://www.federalregister.gov/documents/2023/03/15/2023-04961/medicare-and-medicaid-programs-cy-2023-payment-policies-under-the-physician-fee-schedule-and-other
169 https://www.federalregister.gov/documents/2023/03/10/2023-03649/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug
170 https://www.federalregister.gov/documents/2023/03/10/2023-04550/mammography-quality-standards-act
171 https://www.federalregister.gov/documents/2023/03/02/2023-04010/change-of-address-technical-amendment
172 https://www.federalregister.gov/documents/2023/02/02/2023-02141/medical-devices-hematology-and-pathology-devices-classification-of-the-software-algorithm-device-to
173 https://www.federalregister.gov/documents/2023/02/01/C1-2022-24417/requirements-for-additional-traceability-records-for-certain-foods
174 https://www.federalregister.gov/documents/2023/02/01/2023-01942/medicare-and-medicaid-programs-policy-and-technical-changes-to-the-medicare-advantage-medicare
175 https://www.federalregister.gov/documents/2023/01/31/2023-01967/medical-devices-cardiovascular-devices-classification-of-the-software-for-optical-camera-based
176 https://www.federalregister.gov/documents/2023/01/24/2023-01185/listing-of-color-additives-exempt-from-certification-calcium-carbonate-confirmation-of-effective
177 https://www.federalregister.gov/documents/2023/01/24/2023-01179/clarification-of-orphan-drug-exclusivity-following-catalyst-pharms-inc-v-becerra-notification
178 https://www.federalregister.gov/documents/2023/01/20/2023-01048/medical-devices-gastroenterology-urology-devices-classification-of-the-computerized-behavioral
179 https://www.federalregister.gov/documents/2023/01/20/2023-01049/medical-devices-ophthalmic-devices-classification-of-the-intense-pulsed-light-device-for-managing
180 https://www.federalregister.gov/documents/2023/01/20/2023-00922/radiological-health-regulations-amendments-to-records-and-reports-for-radiation-emitting-electronic
181 https://www.federalregister.gov/documents/2023/01/17/2023-00480/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-prognostic
182 https://www.federalregister.gov/documents/2023/01/17/2023-00718/medicare-program-updates-to-face-to-face-encounter-and-written-order-prior-to-delivery-list
183 https://www.federalregister.gov/documents/2023/01/13/2023-00497/medical-devices-neurological-devices-classification-of-the-digital-therapy-device-to-reduce-sleep
184 https://www.federalregister.gov/documents/2023/01/11/2023-00391/foreign-supplier-verification-programs-for-importers-of-food-for-humans-and-animals-guidance-for
185 https://www.federalregister.gov/documents/2023/01/06/2023-00010/medical-devices-cardiovascular-devices-classification-of-the-hardware-and-software-for-optical
186 https://www.federalregister.gov/documents/2023/01/06/2023-00008/medical-devices-ear-nose-and-throat-devices-classification-of-the-powered-insertion-system-for-a
187 https://www.federalregister.gov/documents/2023/01/06/2023-00012/medical-devices-orthopedic-devices-classification-of-the-resorbable-shoulder-spacer
188 https://www.federalregister.gov/documents/2023/01/06/2023-00007/medical-devices-physical-medicine-devices-classification-of-the-electroencephalography-driven-upper
189 https://www.federalregister.gov/documents/2023/01/06/2023-00014/medical-devices-physical-medicine-devices-classification-of-the-virtual-reality-behavioral-therapy
190 https://www.federalregister.gov/documents/2023/01/05/2022-28428/food-additives-permitted-for-direct-addition-to-food-for-human-consumption-vitamin-d3
191 https://www.federalregister.gov/documents/2023/01/05/2022-28603/medical-devices-neurological-devices-classification-of-the-brain-stimulation-programming-planning
192 https://www.federalregister.gov/documents/2023/01/05/2022-28604/medical-devices-orthopedic-devices-classification-of-the-implantable-post-surgical-kinematic
193 https://www.federalregister.gov/documents/2023/01/05/2022-28601/medical-devices-orthopedic-devices-classification-of-the-bone-indentation-device
194 https://www.federalregister.gov/documents/2023/01/04/2022-28517/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment
195 https://www.federalregister.gov/documents/2023/01/03/2022-27902/uniform-compliance-date-for-food-labeling-regulations
196 https://www.federalregister.gov/documents/2023/01/03/2022-28494/medical-devices-gastroenterology-urology-devices-classification-of-the-gastrointestinal-lesion
197 https://www.federalregister.gov/documents/2022/12/30/2022-28430/medical-devices-neurological-devices-classification-of-the-pediatric-autism-spectrum-disorder
198 https://www.federalregister.gov/documents/2022/12/30/2022-28359/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-and
199 https://www.federalregister.gov/documents/2022/12/30/2022-28364/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis
200 https://www.federalregister.gov/documents/2022/12/29/2022-28168/medical-devices-cardiovascular-devices-classification-of-the-extracorporeal-system-for-carbon
201 https://www.federalregister.gov/documents/2022/12/29/2022-28166/medical-devices-orthopedic-devices-classification-of-the-resorbable-implant-for-anterior-cruciate
202 https://www.federalregister.gov/documents/2022/12/28/2022-28173/medical-devices-cardiovascular-devices-classification-of-the-interventional-cardiovascular-implant
203 https://www.federalregister.gov/documents/2022/12/27/2022-28035/medical-devices-immunology-and-microbiology-devices-classification-of-the-human-leukocyte-antigen
204 https://www.federalregister.gov/documents/2022/12/27/2022-28131/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-hemodynamic-indicator-with
205 https://www.federalregister.gov/documents/2022/12/23/2022-27816/international-dairy-foods-association-and-chobani-inc-response-to-the-objections-and-requests-for-a
206 https://www.federalregister.gov/documents/2022/12/21/2022-27714/best-practices-for-convening-a-gras-panel-guidance-for-industry-availability
207 https://www.federalregister.gov/documents/2022/12/20/2022-27211/basic-health-program-federal-funding-methodology-for-program-year-2023-and-changes-to-the-basic
208 https://www.federalregister.gov/documents/2022/12/15/2022-27040/international-dairy-foods-association-and-chobani-inc-response-to-the-objections-and-requests-for-a
209 https://www.federalregister.gov/documents/2022/12/14/2022-24106/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsor-change-of-sponsor
210 https://www.federalregister.gov/documents/2022/12/14/2022-27147/defining-small-number-of-animals-for-minor-use-determination-periodic-reassessment-confirmation-of
211 https://www.federalregister.gov/documents/2022/12/13/2022-26986/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the
212 https://www.federalregister.gov/documents/2022/11/25/2022-25650/tobacco-products-required-warnings-for-cigarette-packages-and-advertisements-delayed-effective-date
213 https://www.federalregister.gov/documents/2022/11/23/2022-23918/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment
214 https://www.federalregister.gov/documents/2022/11/21/2022-24417/requirements-for-additional-traceability-records-for-certain-foods
215 https://www.federalregister.gov/documents/2022/11/18/2022-23873/medicare-and-medicaid-programs-cy-2023-payment-policies-under-the-physician-fee-schedule-and-other
216 https://www.federalregister.gov/documents/2022/11/17/2022-24990/clinical-laboratory-improvement-amendments-clia-proficiency-testing-related-to-analytes-and
217 https://www.federalregister.gov/documents/2022/11/10/2022-24429/listing-of-color-additives-exempt-from-certification-spirulina-extract
218 https://www.federalregister.gov/documents/2022/11/07/2022-23778/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis
219 https://www.federalregister.gov/documents/2022/11/04/2022-23868/microbiology-devices-reclassification-of-human-immunodeficiency-virus-viral-load-monitoring-tests
220 https://www.federalregister.gov/documents/2022/11/04/2022-24077/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the
221 https://www.federalregister.gov/documents/2022/11/04/2022-23722/medicare-program-calendar-year-cy-2023-home-health-prospective-payment-system-rate-update-home
222 https://www.federalregister.gov/documents/2022/11/03/2022-23407/medicare-program-implementing-certain-provisions-of-the-consolidated-appropriations-act-2021-and
223 https://www.federalregister.gov/documents/2022/11/01/2022-23573/regulation-of-human-cells-tissues-and-cellular-and-tissue-based-products-small-entity-compliance
224 https://www.federalregister.gov/documents/2022/10/31/2022-23534/current-good-manufacturing-practice-hazard-analysis-and-risk-based-preventive-controls-for-human
225 https://www.federalregister.gov/documents/2022/10/21/2022-22876/extension-of-the-period-before-the-food-and-drug-administration-intends-to-begin-enforcing-the
226 https://www.federalregister.gov/documents/2022/10/20/2022-22706/laboratory-accreditation-for-analyses-of-foods-small-entity-compliance-guide-availability
227 https://www.federalregister.gov/documents/2022/10/18/2022-22532/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment-for
228 https://www.federalregister.gov/documents/2022/09/29/2022-20836/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-new-animal-drug
229 https://www.federalregister.gov/documents/2022/09/29/2022-21193/standards-for-the-electronic-health-record-technology-incentive-program
230 https://www.federalregister.gov/documents/2022/09/27/2022-20819/listing-of-color-additives-exempt-from-certification-calcium-carbonate
231 https://www.federalregister.gov/documents/2022/09/27/2022-20973/medicaid-program-temporary-increase-in-federal-medical-assistance-percentage-fmap-in-response-to-the
232 https://www.federalregister.gov/documents/2022/09/15/2022-19954/defining-small-number-of-animals-for-minor-use-determination-periodic-reassessment
233 https://www.federalregister.gov/documents/2022/09/14/2022-19737/annual-summary-reporting-requirements-under-the-right-to-try-act
234 https://www.federalregister.gov/documents/2022/09/13/2022-19736/public-information
235 https://www.federalregister.gov/documents/2022/09/07/2022-19277/listing-of-color-additives-of-color-additives-exempt-from-certification-antarctic-krill-meal
236 https://www.federalregister.gov/documents/2022/08/29/2022-18539/food-additives-permitted-in-feed-and-drinking-water-of-animals-fumonisin-esterase
237 https://www.federalregister.gov/documents/2022/08/29/2022-18541/radiation-oncology-ro-model
238 https://www.federalregister.gov/documents/2022/08/18/2022-17761/tobacco-products-required-warnings-for-cigarette-packages-and-advertisements-delayed-effective-date
239 https://www.federalregister.gov/documents/2022/08/17/2022-17231/regulatory-requirements-for-hearing-aid-devices-and-personal-sound-amplification-products-guidance
240 https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids
241 https://www.federalregister.gov/documents/2022/08/11/2022-17247/prevention-of-salmonella-enteritidis-in-shell-eggs-during-production-storage-and-transportation
242 https://www.federalregister.gov/documents/2022/08/10/2022-17187/medicare-program-suspension-of-required-prior-authorization-for-certain-durable-medical-equipment
243 https://www.federalregister.gov/documents/2022/08/10/2022-17186/medicare-program-alternative-payment-model-apm-incentive-payment-advisory-for-clinicians-request-for
244 https://www.federalregister.gov/documents/2022/08/10/2022-16472/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the
245 https://www.federalregister.gov/documents/2022/08/03/2022-16566/food-additives-permitted-in-feed-and-drinking-water-of-animals-fumonisin-esterase
246 https://www.federalregister.gov/documents/2022/08/03/2022-16457/medicare-program-prospective-payment-system-and-consolidated-billing-for-skilled-nursing-facilities
247 https://www.federalregister.gov/documents/2022/08/01/2022-16225/medicare-program-inpatient-rehabilitation-facility-prospective-payment-system-for-federal-fiscal
248 https://www.federalregister.gov/documents/2022/07/29/2022-16214/medicare-program-fy-2023-hospice-wage-index-and-payment-rate-update-and-hospice-quality-reporting
249 https://www.federalregister.gov/documents/2022/07/29/2022-16260/medicare-program-fy-2023-inpatient-psychiatric-facilities-prospective-payment-system-rate-update-and
250 https://www.federalregister.gov/documents/2022/07/25/2022-15828/unique-device-identification-policy-regarding-compliance-dates-for-class-i-and-unclassified-devices
251 https://www.federalregister.gov/documents/2022/07/14/2022-15062/medicare-program-mips-payment-adjustment-exception-applicable-for-enhancing-oncology-model-monthly
252 https://www.federalregister.gov/documents/2022/07/11/2022-14513/clinical-laboratory-improvement-amendments-of-1988-clia-proficiency-testing-regulations-related-to
253 https://www.federalregister.gov/documents/2022/06/29/2022-13993/survey-certification-and-enforcement-procedures
254 https://www.federalregister.gov/documents/2022/06/17/2022-13052/medicare-program-accrediting-organizations-changes-of-ownership-correction
255 https://www.federalregister.gov/documents/2022/06/08/2022-12364/medical-devices-cardiovascular-devices-classification-of-the-intravascular-bleed-monitor
256 https://www.federalregister.gov/documents/2022/06/06/2022-12082/medical-devices-gastroenterology-urology-devices-classification-of-the-non-implanted-electrical
257 https://www.federalregister.gov/documents/2022/06/01/2022-11699/medical-devices-cardiovascular-devices-classification-of-the-coronary-artery-disease-risk-indicator
258 https://www.federalregister.gov/documents/2022/06/01/2022-11568/tobacco-products-required-warnings-for-cigarette-packages-and-advertisements-delayed-effective-date
259 https://www.federalregister.gov/documents/2022/05/27/2022-11477/withdrawing-rule-on-securing-updated-and-necessary-statutory-evaluations-timely
260 https://www.federalregister.gov/documents/2022/05/26/2022-11276/importation-of-prescription-drugs-final-rule-questions-and-answers-guidance-for-industry-small
261 https://www.federalregister.gov/documents/2022/05/20/2022-10531/indirect-food-additives-adhesives-and-components-of-coatings-paper-and-paperboard-components
262 https://www.federalregister.gov/documents/2022/05/16/2022-10461/microbiology-devices-reclassification-of-human-immunodeficiency-virus-serological-diagnostic-and
263 https://www.federalregister.gov/documents/2022/05/16/2022-10225/medicaid-program-reassignment-of-medicaid-provider-claims
264 https://www.federalregister.gov/documents/2022/05/10/2022-10025/listing-of-color-additives-exempt-from-certification-antarctic-krill-meal
265 https://www.federalregister.gov/documents/2022/05/09/2022-09375/medicare-program-contract-year-2023-policy-and-technical-changes-to-the-medicare-advantage-and
266 https://www.federalregister.gov/documents/2022/05/06/2022-09745/medical-devices-cardiovascular-devices-classification-of-the-reverse-central-venous-recanalization
267 https://www.federalregister.gov/documents/2022/05/06/2022-09735/medical-devices-gastroenterology-urology-devices-classification-of-the-magnetically-maneuvered
268 https://www.federalregister.gov/documents/2022/05/06/2022-09749/medical-devices-general-and-plastic-surgery-devices-classification-of-the-mountable
269 https://www.federalregister.gov/documents/2022/04/29/2022-09102/medicare-program-accrediting-organizations-changes-of-ownership
270 https://www.federalregister.gov/documents/2022/04/25/2022-08731/medical-devices-general-and-plastic-surgery-devices-classification-of-the-autofluorescence-detection
271 https://www.federalregister.gov/documents/2022/04/20/2022-08273/beverages-bottled-water
272 https://www.federalregister.gov/documents/2022/04/14/2022-07642/medicare-program-maximum-out-of-pocket-moop-limits-and-service-category-cost-sharing-standards
273 https://www.federalregister.gov/documents/2022/04/11/2022-07680/food-additives-permitted-in-feed-and-drinking-water-of-animals-methyl-esters-of-conjugated-linoleic
274 https://www.federalregister.gov/documents/2022/03/29/2022-06677/food-additives
275 https://www.federalregister.gov/documents/2022/03/29/2022-06395/new-animal-drugs-approval-of-new-animal-drug-applications-change-of-sponsor
276 https://www.federalregister.gov/documents/2022/03/29/2022-06508/medical-devices-technical-amendments
277 https://www.federalregister.gov/documents/2022/03/25/2022-06495/food-labeling
278 https://www.federalregister.gov/documents/2022/03/23/2022-05776/certain-ophthalmic-products-policy-regarding-compliance-with-21-cfr-part-4-guidance-for-industry
279 https://www.federalregister.gov/documents/2022/03/23/2022-05965/advisory-committee-bone-reproductive-and-urologic-drugs-advisory-committee-change-of-name-and
280 https://www.federalregister.gov/documents/2022/03/23/2022-05804/milk-and-cream-petition-for-an-administrative-stay-of-action-definitions-and-standards-of-identity
281 https://www.federalregister.gov/documents/2022/03/14/2022-05315/current-good-manufacturing-practice-and-preventive-controls-foreign-supplier-verification-programs
282 https://www.federalregister.gov/documents/2022/03/14/2022-05303/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the
283 https://www.federalregister.gov/documents/2022/03/04/2022-04704/initiation-of-voluntary-recalls-guidance-for-industry-and-food-and-drug-administration-staff
284 https://www.federalregister.gov/documents/2022/03/04/2022-04524/securing-updated-and-necessary-statutory-evaluations-timely-administrative-delay-of-effective-date
285 https://www.federalregister.gov/documents/2022/03/01/2022-04154/medical-devices-orthopedic-devices-classification-of-the-screw-sleeve-bone-fixation-device
286 https://www.federalregister.gov/documents/2022/03/01/2022-04181/tobacco-products-required-warnings-for-cigarette-packages-and-advertisements-delayed-effective-date
287 https://www.federalregister.gov/documents/2022/02/28/2022-03538/new-animal-drugs-approval-of-new-animal-drug-applications-withdrawal-of-approval-of-a-new-animal
288 https://www.federalregister.gov/documents/2022/02/18/2022-03504/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-integrated
289 https://www.federalregister.gov/documents/2022/02/18/2022-03496/medical-devices-cardiovascular-devices-classification-of-the-percutaneous-catheter-for-creation-of
290 https://www.federalregister.gov/documents/2022/02/18/2022-03540/medical-devices-ophthalmic-devices-classification-of-the-electromechanical-tear-stimulator
291 https://www.federalregister.gov/documents/2022/02/14/2022-03096/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-predictive-cardiovascular
292 https://www.federalregister.gov/documents/2022/02/14/2022-03104/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-spore-test-strip
293 https://www.federalregister.gov/documents/2022/02/10/2022-02623/medicare-program-cy-2022-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part
294 https://www.federalregister.gov/documents/2022/02/04/2022-02368/medical-devices-immunology-and-microbiology-devices-classification-of-the-system-for-detection-of
295 https://www.federalregister.gov/documents/2022/02/04/2022-02358/medical-devices-cardiovascular-devices-classification-of-the-photoplethysmograph-analysis-software
296 https://www.federalregister.gov/documents/2022/02/04/2022-02357/medical-devices-general-and-plastic-surgery-devices-classification-of-the-carbon-dioxide-gas
297 https://www.federalregister.gov/documents/2022/02/04/2022-02369/medical-devices-general-hospital-and-personal-use-devices-classification-of-the-alternate-controller
298 https://www.federalregister.gov/documents/2022/02/02/2022-02046/laboratory-accreditation-for-analyses-of-foods-correction
299 https://www.federalregister.gov/documents/2022/01/27/C1-2021-27523/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-changes-to
300 https://www.federalregister.gov/documents/2022/01/21/2022-01147/medical-devices-ophthalmic-devices-classification-of-the-retinal-diagnostic-software-device
301 https://www.federalregister.gov/documents/2022/01/18/2022-00827/medical-devices-cardiovascular-devices-classification-of-the-electrocardiograph-software-for
302 https://www.federalregister.gov/documents/2022/01/18/2022-00816/new-method-for-the-analysis-of-sulfites-in-foods
303 https://www.federalregister.gov/documents/2022/01/13/2022-00572/medicare-program-updates-to-lists-related-to-durable-medical-equipment-prosthetics-orthotics-and
304 https://www.federalregister.gov/documents/2022/01/13/2022-00494/french-dressing-revocation-of-a-standard-of-identity
305 https://www.federalregister.gov/documents/2022/01/13/2022-00501/revised-procedures-for-the-announcement-of-approvals-and-denials-of-premarket-approval-applications
306 https://www.federalregister.gov/documents/2022/01/13/2022-00492/revocation-of-the-regulations-for-human-tissue-intended-for-transplantation-and-human-dura-mater
307 https://www.federalregister.gov/documents/2022/01/13/2022-00573/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment
308 https://www.federalregister.gov/documents/2022/01/04/C1-2021-27763/medicare-program-durable-medical-equipment-prosthetics-orthotics-and-supplies-dmepos-policy-issues
309 https://www.federalregister.gov/documents/2021/12/29/2021-28159/listing-of-color-additives-exempt-from-certification-butterfly-pea-flower-extract-confirmation-of
310 https://www.federalregister.gov/documents/2021/12/29/2021-28158/listing-of-color-additives-exempt-from-certification-silver-nitrate-confirmation-of-effective-date
311 https://www.federalregister.gov/documents/2021/12/29/2021-28163/medical-devices-gastroenterology-urology-devices-classification-of-the-transcutaneous-electrical
312 https://www.federalregister.gov/documents/2021/12/29/2021-28160/medical-devices-neurological-devices-classification-of-the-diagnostic-neurosurgical-microscope
313 https://www.federalregister.gov/documents/2021/12/29/2021-28157/medical-devices-neurological-devices-classification-of-the-cerebrospinal-fluid-shunt-system
314 https://www.federalregister.gov/documents/2021/12/29/2021-28225/most-favored-nation-mfn-model
315 https://www.federalregister.gov/documents/2021/12/28/2021-27763/medicare-program-durable-medical-equipment-prosthetics-orthotics-and-supplies-dmepos-policy-issues
316 https://www.federalregister.gov/documents/2021/12/28/2021-28166/medical-devices-anesthesiology-devices-classification-of-the-retrograde-intubation-device
317 https://www.federalregister.gov/documents/2021/12/27/2021-27853/medicare-program-cy-2022-payment-policies-under-the-physician-fee-schedule-and-other-changes-to-part
318 https://www.federalregister.gov/documents/2021/12/27/2021-27523/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-changes-to
319 https://www.federalregister.gov/documents/2021/12/22/2021-27568/medicare-and-medicaid-programs-cy-2022-home-health-prospective-payment-system-rate-update-home
320 https://www.federalregister.gov/documents/2021/12/17/2021-27317/medical-devices-general-and-plastic-surgery-devices-classification-of-the-manual-percutaneous
321 https://www.federalregister.gov/documents/2021/12/17/2021-27452/medicaid-program-delay-of-effective-date-for-provision-relating-to-manufacturer-reporting-of
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325 https://www.federalregister.gov/documents/2021/12/14/2021-26914/medicare-program-end-stage-renal-disease-prospective-payment-system-payment-for-renal-dialysis
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638 https://www.federalregister.gov/documents/2018/06/14/2018-12760/medical-devices-immunology-and-microbiology-devices-classification-of-the-brain-trauma-assessment
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655 https://www.federalregister.gov/documents/2018/05/04/2018-09434/general-hospital-and-personal-use-devices-reclassification-of-sharps-needle-destruction-device
656 https://www.federalregister.gov/documents/2018/05/04/2018-09476/food-labeling-revision-of-the-nutrition-and-supplement-facts-labels-and-serving-sizes-of-foods-that
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666 https://www.federalregister.gov/documents/2018/03/29/2018-06252/good-guidance-practices-technical-amendment
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679 https://www.federalregister.gov/documents/2018/02/05/2018-02202/medical-devices-neurological-devices-classification-of-the-percutaneous-nerve-stimulator-for
680 https://www.federalregister.gov/documents/2018/01/31/2018-01912/listing-of-color-additives-exempt-from-certification-calcium-carbonate-confirmation-of-effective
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682 https://www.federalregister.gov/documents/2018/01/30/2018-01638/medical-devices-cardiovascular-devices-classification-of-the-temporary-catheter-for-embolic
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687 https://www.federalregister.gov/documents/2018/01/05/2018-00051/medical-devices-radiology-devices-classification-of-the-absorbable-perirectal-spacer
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691 https://www.federalregister.gov/documents/2018/01/02/2017-28262/medical-devices-hematology-and-pathology-devices-classification-of-the-whole-slide-imaging-system
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721 https://www.federalregister.gov/documents/2017/11/07/2017-24161/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-total
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723 https://www.federalregister.gov/documents/2017/11/07/2017-24162/medical-devices-exemption-from-premarket-notification-class-ii-devices-autosomal-recessive-carrier
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731 https://www.federalregister.gov/documents/2017/10/30/2017-23491/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-the-acute
732 https://www.federalregister.gov/documents/2017/10/30/2017-23516/medical-devices-neurological-devices-classification-of-the-non-electroencephalogram-physiological
733 https://www.federalregister.gov/documents/2017/10/30/2017-23489/medical-devices-immunology-and-microbiology-devices-classification-of-the-aquaporin-4-autoantibody
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735 https://www.federalregister.gov/documents/2017/10/24/2017-23022/medical-devices-immunology-and-microbiology-devices-classification-of-the-mass-spectrometer-system
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741 https://www.federalregister.gov/documents/2017/10/16/2017-22305/medical-devices-immunology-and-microbiology-devices-classification-of-the-automated-image-assessment
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743 https://www.federalregister.gov/documents/2017/10/12/2017-21982/medical-devices-neurological-devices-classification-of-cranial-motion-measurement-device-correction
744 https://www.federalregister.gov/documents/2017/10/10/2017-21659/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-cardiovascular-status
745 https://www.federalregister.gov/documents/2017/10/04/2017-21325/medicare-program-hospital-inpatient-prospective-payment-systems-for-acute-care-hospitals-and-the
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752 https://www.federalregister.gov/documents/2017/08/25/2017-18028/mitigation-strategies-to-protect-food-against-intentional-adulteration-what-you-need-to-know-about
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760 https://www.federalregister.gov/documents/2017/07/28/2017-15901/medical-devices-cardiovascular-devices-classification-of-the-adjunctive-cardiovascular-status
761 https://www.federalregister.gov/documents/2017/07/28/2017-15894/medical-devices-gastroenterology-urology-devices-classification-of-the-oral-removable-palatal-space
762 https://www.federalregister.gov/documents/2017/07/28/2017-15895/medical-devices-neurological-devices-classification-of-cranial-motion-measurement-device
763 https://www.federalregister.gov/documents/2017/07/28/2017-15892/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-closed-loop
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765 https://www.federalregister.gov/documents/2017/07/27/2017-15858/medical-devices-immunology-and-microbiology-devices-classification-of-the-assayed-quality-control
766 https://www.federalregister.gov/documents/2017/07/27/2017-15786/medical-devices-cardiovascular-devices-classification-of-the-balloon-aortic-valvuloplasty-catheter
767 https://www.federalregister.gov/documents/2017/07/25/2017-15538/food-labeling-nutrition-labeling-of-standard-menu-items-in-restaurants-and-similar-retail-food
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987 https://www.federalregister.gov/documents/2016/02/04/2016-02055/state-health-insurance-assistance-program-ship
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1000 2016-01-04 2016 January
